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    Clinical Trial Results:
    A prospective, randomized, double-blind, placebo-controlled, multicenter study with an open-label extension period to investigate the efficacy and safety of NT 201 in the combined treatment of upper facial lines (horizontal forehead lines, glabellar frown lines, and lateral periorbital lines)

    Summary
    EudraCT number
    		 2011-005887-20
    Trial protocol
    		 DE   GB  
    Global end of trial date
    05 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Mar 2016
    First version publication date
    25 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MRZ60201_3076_1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merz Pharmaceuticals GmbH
    Sponsor organisation address
    Eckenheimer Landstrasse 100, Frankfurt/M, Germany, 60318
    Public contact
    Public Disclosure Manager, Merz Pharmaceuticals GmbH, clinicaltrials@merz.de
    Scientific contact
    Public Disclosure Manager, Merz Pharmaceuticals GmbH, clinicaltrials@merz.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Nov 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Feb 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy and safety of 54 to 64 Units of NT 201 intramuscularly administered in subjects with moderate to severe upper facial lines.
    Protection of trial subjects
    High medical and ethical standards were followed in accordance with Good Clinical Practice and other applicable regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jul 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 24
    Country: Number of subjects enrolled
    France: 29
    Country: Number of subjects enrolled
    Germany: 103
    Worldwide total number of subjects
    156
    EEA total number of subjects
    156
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    148
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening failures were mainly caused by the FLQA-k inclusion criterion (calculated cut-off-score below 0).

    Period 1
    Period 1 title
    Main Period (MP)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NT 201
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    NT 201
    Investigational medicinal product code
    Other name
    Botulinum neurotoxin type A free from complexing proteins, Xeomin, Bocouture, incobotulinumtoxinA
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Dose: 54 to 64 U, mode of administration: of the total injection volume (1.35 to 1.6 mL), the following aliquots were administered intramuscularly: HFL (a flexible dose within a range of 10 to 20 Units [U] individually adjusted according to the subject’s age, gender and dermal and muscular conditions [such as individual muscle mass, muscle activity, muscle looseness/compliance, brow position, and brow shape] as assessed by the investigator distributed to 5 horizontally orientated points), GFL (20 U in equal aliquots administered in 5 points), LPL (12 U in equal aliquots administered in 3 points per eye area [24 U Overall]).

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A total volume of 1.35 to 1.6 mL placebo solution were injected in the same areas and in the same manner as NT 201.

    Number of subjects in period 1
    		NT 201 Placebo
    Started
    105
    51
    Completed
    103
    46
    Not completed
    2
    5
         Consent withdrawn by subject
    -
    1
         Lost to follow-up
    2
    4
    Period 2
    Period 2 title
    Open label extension (OLEX)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 NT 201
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    NT 201
    Investigational medicinal product code
    Other name
    Botulinum neurotoxin type A free from complexing proteins, Xeomin, Bocouture, incobotulinumtoxinA
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Dose: 54 to 64 U, mode of administration: of the total injection volume (1.35 to 1.6 mL), the following aliquots were administered intramuscularly: HFL (a flexible dose within a range of 10 to 20 Units [U] individually adjusted according to the subject’s age, gender and dermal and muscular conditions [such as individual muscle mass, muscle activity, muscle looseness/compliance, brow position, and brow shape] as assessed by the investigator distributed to 5 horizontally orientated points), GFL (20 U in equal aliquots administered in 5 points), LPL (12 U in equal aliquots administered in 3 points per eye area [24 U Overall]).

    Number of subjects in period 2 [1]
    		NT 201
    Started
    139
    Completed
    132
    Not completed
    7
         Consent withdrawn by subject
    2
         Lost to follow-up
    5
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all subjects who completed the main period fulfilled the eligibility criteria for inclusion into the OLEX period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    NT 201
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 NT 201 Placebo Total
    Number of subjects
    		 105 51 156
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 99 49 148
        From 65-84 years
    		 6 2 8
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.4 ± 10.1 47.5 ± 8.4 -
    Gender categorical
    Units: Subjects
        Female
    		 94 41 135
        Male
    		 11 10 21
    Ethnic origin/race
    Units: Subjects
        White
    		 102 50 152
        Black or African American
    		 2 1 3
        Asian
    		 0 0 0
        Other
    		 1 0 1
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS was the subset of subjects in the safety evaluation set (SES) MP for whom the primary efficacy variables were available (i.e., all subjects who had a post-baseline value at V4 of the primary efficacy variables including imputed values).

    Subject analysis sets values
    		 Full Analysis Set (FAS)
    Number of subjects
    156
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    148
        From 65-84 years
    8
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    47.5 ± 9.5
    Gender categorical
    Units: Subjects
        Female
    135
        Male
    21
    Ethnic origin/race
    Units: Subjects
        White
    152
        Black or African American
    3
        Asian
    0
        Other
    1

    End points

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    End points reporting groups
    Reporting group title
    NT 201
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    NT 201
    Reporting group description
    		 -

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS was the subset of subjects in the safety evaluation set (SES) MP for whom the primary efficacy variables were available (i.e., all subjects who had a post-baseline value at V4 of the primary efficacy variables including imputed values).

    Primary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D30 for GFL

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    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D30 for GFL
    End point description
    End point type
    Primary
    End point timeframe
    Day 30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    105
    51
    156
    Units: Responders
    87
    0
    87
    Statistical analysis title
    		 Primary efficacy analysis
    Comparison groups
    NT 201 v Placebo
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [1] - Hierarchical test procedure: 1st step GFL, 2nd step HFL, 3rd step LPL, 4th step combined Response.

    Primary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D30 for HFL

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    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D30 for HFL
    End point description
    End point type
    Primary
    End point timeframe
    D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    105
    51
    156
    Units: Responders
    75
    1
    76
    Statistical analysis title
    		 Primary efficacy analysis
    Comparison groups
    NT 201 v Placebo
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [2] - Hierarchical test procedure: 1st step GFL, 2nd step HFL, 3rd step LPL, 4th step combined Response.

    Primary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D30 for LPL

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    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D30 for LPL
    End point description
    End point type
    Primary
    End point timeframe
    D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    105
    51
    156
    Units: Responders
    67
    1
    68
    Statistical analysis title
    		 Primary efficacy analysis
    Comparison groups
    Placebo v NT 201
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [3] - Hierarchical test procedure: 1st step GFL, 2nd step HFL, 3rd step LPL, 4th step combined Response.

    Primary: Combined response defined as Investigator MAS rating sum score of 3 or lower at max. contraction at D30

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    End point title
    		 Combined response defined as Investigator MAS rating sum score of 3 or lower at max. contraction at D30
    End point description
    End point type
    Primary
    End point timeframe
    D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    105
    51
    156
    Units: Responders
    57
    0
    57
    Statistical analysis title
    		 Primary efficacy analysis
    Comparison groups
    NT 201 v Placebo
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001 [4]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [4] - Hierarchical test procedure: 1st step GFL, 2nd step HFL, 3rd step LPL, 4th step combined Response.

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D8 for GFL

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    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D8 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    105
    51
    156
    Units: Responders
    84
    1
    85
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at maximum contraction at D8 for HFL

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    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at maximum contraction at D8 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    71
    1
    72
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D8 for LPL

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    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D8 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    54
    1
    55
    No statistical analyses for this end point

    Secondary: Combined response defined as Investigator MAS rating sum score of 3 or lower at max. contraction at Day 8

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    End point title
    		 Combined response defined as Investigator MAS rating sum score of 3 or lower at max. contraction at Day 8
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    47
    0
    47
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D60 for GFL

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    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D60 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    68
    0
    68
    No statistical analyses for this end point

    Secondary: Response defined as investigator MAS rating 0 or 1 at max. contraction at D60 for HFL

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    End point title
    		 Response defined as investigator MAS rating 0 or 1 at max. contraction at D60 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    56
    2
    58
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at Day 60 for LPL

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    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at Day 60 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    46
    2
    48
    No statistical analyses for this end point

    Secondary: Combined response defined as Investigator MAS rating sum score of 3 or lower at max. contraction at Day 60

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    End point title
    		 Combined response defined as Investigator MAS rating sum score of 3 or lower at max. contraction at Day 60
    End point description
    End point type
    Secondary
    End point timeframe
    D60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    34
    0
    34
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D90 for GFL

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    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D90 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    54
    1
    55
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D90 for HFL

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    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D90 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    38
    1
    39
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D90 for LPL

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    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D90 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    24
    3
    27
    No statistical analyses for this end point

    Secondary: Combined response defined as Investigator MAS rating sum score of 3 or lower at max. contraction at D90

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    End point title
    		 Combined response defined as Investigator MAS rating sum score of 3 or lower at max. contraction at D90
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    15
    0
    15
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D120 for GFL

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    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D120 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    14
    0
    14
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D120 for HFL

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    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D120 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    9
    0
    9
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D120 for LPL

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    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D120 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    5
    0
    5
    No statistical analyses for this end point

    Secondary: Combined response defined as Investigator MAS rating sum score of 3 or lower at max. contraction at D120

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    End point title
    		 Combined response defined as Investigator MAS rating sum score of 3 or lower at max. contraction at D120
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    2
    0
    2
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D8 for GFL

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    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D8 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    61
    0
    61
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D8 for HFL

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    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D8 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    55
    2
    57
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D8 for LPL

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    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D8 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    38
    2
    40
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D30 for GFL

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    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D30 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    70
    0
    70
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D30 for HFL

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    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D30 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    60
    3
    63
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D30 for LPL

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    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D30 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    43
    2
    45
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D60 for GFL

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    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D60 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    47
    0
    47
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D60 for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D60 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    38
    2
    40
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D60 for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D60 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    25
    3
    28
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D90 for GFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D90 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    35
    0
    35
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D90 for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D90 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    25
    2
    27
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D90 for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D90 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    16
    1
    17
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D120 for GFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D120 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    17
    0
    17
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D120 for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D120 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    6
    1
    7
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D120 for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D120 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    7
    0
    7
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D8 for GFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D8 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    95
    23
    118
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D8 for HFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D8 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    95
    20
    115
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D8 for LPL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D8 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    85
    23
    108
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D30 for GFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D30 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    97
    22
    119
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D30 for HFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D30 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    94
    22
    116
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D30 for LPL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D30 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    89
    20
    109
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D60 for GFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D60 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    91
    20
    111
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D60 for HFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D60 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    91
    22
    113
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D60 for LPL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D60 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    89
    19
    108
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D90 for GFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D90 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    83
    21
    104
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D90 for HFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D90 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    79
    19
    98
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D90 for LPL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D90 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    78
    19
    97
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D120 for GFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D120 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    80
    20
    100
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D120 for HFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D120 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    67
    23
    90
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D120 for LPL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D120 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    61
    22
    83
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D8 for GFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D8 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    76
    14
    90
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D8 for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D8 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    83
    15
    98
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D8 for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D8 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    72
    9
    81
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D30 for GFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D30 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    87
    13
    100
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D30 for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D30 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    87
    19
    106
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D30 for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D30 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    72
    14
    86
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D60 for GFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D60 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    81
    8
    89
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D60 for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D60 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    82
    16
    98
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D60 for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D60 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    74
    10
    84
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D90 for GFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D90 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    72
    9
    81
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D90 for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D90 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    71
    16
    87
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D90 for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D90 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    59
    9
    68
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D120 for GFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D120 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    63
    9
    72
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D120 for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D120 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    58
    14
    72
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D120 for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D120 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    47
    10
    57
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D8 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D8 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    102
    3
    105
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D8 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D8 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    97
    5
    102
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D8 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D8 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    96
    9
    105
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D30 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D30 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    98
    3
    101
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D30 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D30 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    94
    2
    96
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D30 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D30 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    96
    7
    103
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D60 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D60 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Rersponders
    90
    5
    95
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D60 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D60 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    83
    6
    89
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D60 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D60 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    82
    6
    88
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D90 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D90 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    77
    3
    80
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D90 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D90 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    68
    5
    73
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D90 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D90 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    63
    8
    71
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D120 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D120 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    43
    1
    44
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D120 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D120 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    43
    3
    46
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D120 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D120 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    Day 120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    31
    7
    38
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D8 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D8 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    66
    5
    71
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D8 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D8 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    80
    4
    84
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D8 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D8 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    73
    6
    79
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D30 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D30 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    69
    5
    74
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D30 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D30 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    87
    4
    91
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D30 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D30 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    81
    5
    86
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D60 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D60 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    64
    5
    69
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D60 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D60 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    78
    7
    85
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D60 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D60 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    80
    4
    84
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D90 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D90 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    55
    6
    61
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D90 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D90 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    69
    7
    76
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D90 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D90 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    65
    7
    72
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D120 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D120 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    41
    4
    45
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D120 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D120 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    47
    6
    53
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D120 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D120 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    47
    10
    57
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D8 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D8 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    87
    12
    99
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D8 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D8 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    86
    10
    96
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D8 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D8 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    82
    8
    90
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D30 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D30 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    90
    7
    97
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D30 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D30 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    92
    6
    98
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D30 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D30 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    83
    8
    91
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D60 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D60 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    87
    5
    92
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D60 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D60 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    83
    12
    95
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D60 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D60 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    76
    10
    86
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D90 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D90 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    69
    8
    77
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D90 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D90 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    73
    14
    87
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D90 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D90 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    61
    11
    72
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D120 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D120 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    53
    8
    61
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D120 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D120 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    54
    12
    66
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D120 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D120 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    51
    13
    64
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D8 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D8 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    68
    16
    84
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D8 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D8 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    78
    9
    87
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D8 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D8 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    104
    51
    155
    Units: Responders
    72
    9
    81
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D30 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D30 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    78
    14
    92
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D30 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D30 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    86
    8
    94
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D30 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D30 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    76
    12
    88
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D60 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D60 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    72
    11
    83
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D60 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D60 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    79
    8
    87
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D60 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D60 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D 60 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    102
    46
    148
    Units: Responders
    74
    9
    83
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D90 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D90 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    66
    13
    79
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D90 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D90 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    68
    8
    76
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D90 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D90 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D90 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    101
    46
    147
    Units: Responders
    67
    6
    73
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D120 for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D120 for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    51
    11
    62
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D120 for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D120 for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    57
    5
    62
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D120 for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D120 for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    46
    149
    Units: Responders
    52
    5
    57
    No statistical analyses for this end point

    Secondary: Response defined as Investigator rating score of much improved (+2) or very much improved (+3) at D30 for the overall appearance of the upper face according to Global impression of Change Scale (GICS)

    		 Close Top of page
    End point title
    		 Response defined as Investigator rating score of much improved (+2) or very much improved (+3) at D30 for the overall appearance of the upper face according to Global impression of Change Scale (GICS)
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    89
    1
    90
    No statistical analyses for this end point

    Secondary: Response defined as Subject rating score of much improved (+2) or very much improved (+3) at D30 for the overall appearance of the upper face according to Global impression of Change Scale (GICS)

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    End point title
    		 Response defined as Subject rating score of much improved (+2) or very much improved (+3) at D30 for the overall appearance of the upper face according to Global impression of Change Scale (GICS)
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    103
    48
    151
    Units: Responders
    80
    1
    81
    No statistical analyses for this end point

    Secondary: Onset of effect by D8 for GFL as reported by Subject according to diary

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    End point title
    		 Onset of effect by D8 for GFL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Up to D8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    105
    51
    156
    Units: Onsets
    90
    7
    97
    No statistical analyses for this end point

    Secondary: Onset of effect by D8 for HFL as reported by Subject according to diary

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    End point title
    		 Onset of effect by D8 for HFL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Up to D8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    105
    51
    156
    Units: Onsets
    95
    6
    101
    No statistical analyses for this end point

    Secondary: Onset of effect by D8 for left LPL as reported by Subject according to diary

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    End point title
    		 Onset of effect by D8 for left LPL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Up to D8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    105
    51
    156
    Units: Onsets
    77
    9
    86
    No statistical analyses for this end point

    Secondary: Onset of effect by D8 for right LPL as reported by Subject according to diary

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    End point title
    		 Onset of effect by D8 for right LPL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Up to D8 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    105
    51
    156
    Units: Onsets
    76
    10
    86
    No statistical analyses for this end point

    Secondary: Onset of effect between D8 and Day 30 for GFL as reported by Subject according to diary

    		 Close Top of page
    End point title
    		 Onset of effect between D8 and Day 30 for GFL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Between D8 and D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    105
    51
    156
    Units: Onsets
    8
    0
    8
    No statistical analyses for this end point

    Secondary: Onset of effect between D8 and D30 for HFL as reported by Subject according to diary

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    End point title
    		 Onset of effect between D8 and D30 for HFL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Between D8 and D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    105
    51
    156
    Units: Onsets
    4
    0
    4
    No statistical analyses for this end point

    Secondary: Onset of effect between D8 and D30 for left LPL as reported by Subject according to diary

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    End point title
    		 Onset of effect between D8 and D30 for left LPL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Between D8 and D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    105
    51
    156
    Units: Onsets
    11
    1
    12
    No statistical analyses for this end point

    Secondary: Onset of effect between D8 and D30 for right LPL as reported by Subject according to diary

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    End point title
    		 Onset of effect between D8 and D30 for right LPL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Between D8 and D30 after MP injection
    End point values
    		 NT 201 Placebo Full Analysis Set (FAS)
    Number of subjects analysed
    105
    51
    156
    Units: Onsets
    11
    0
    11
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D8 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D8 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    106
    106
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D8 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D8 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    106
    106
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D8 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D8 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    86
    86
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D30 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D30 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    109
    109
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D30 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D30 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    105
    105
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D30 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D30 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    91
    91
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D75 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D75 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    84
    84
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D75 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D75 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    72
    72
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D75 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D75 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    55
    55
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D120 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D120 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    48
    48
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D120 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D120 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    33
    33
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at max. contraction at D120 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at max. contraction at D120 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    19
    19
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D8 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D8 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    85
    85
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D8 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D8 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    92
    92
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D8 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D8 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    71
    71
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D30 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D30 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    82
    82
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D30 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D30 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    97
    97
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D30 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D30 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    63
    63
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D75 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D75 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    60
    60
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D75 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D75 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    49
    49
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D75 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D75 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    40
    40
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D120 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D120 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    35
    35
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D120 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D120 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    19
    19
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at max. contraction at D120 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at max. contraction at D120 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    16
    16
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D8 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D8 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    119
    119
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D8 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D8 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    129
    129
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D8 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D8 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    126
    126
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D30 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D30 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    123
    123
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D30 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D30 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    130
    130
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D30 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D30 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    125
    125
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D75 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D75 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    112
    112
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D75 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D75 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    119
    119
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D75 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D75 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    113
    113
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D120 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D120 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    103
    103
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D120 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D120 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    107
    107
    No statistical analyses for this end point

    Secondary: Response defined as Investigator MAS rating 0 or 1 at rest at D120 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Investigator MAS rating 0 or 1 at rest at D120 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    95
    95
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D8 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D8 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    106
    106
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D8 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D8 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    127
    127
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D8 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D8 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    112
    112
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D30 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D30 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    116
    116
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D30 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D30 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    127
    127
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D30 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D30 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    118
    118
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D75 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D75 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 afte4r OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    101
    101
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D75 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D75 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    110
    110
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D75 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D75 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    99
    99
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D120 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D120 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    84
    84
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D120 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D120 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    94
    94
    No statistical analyses for this end point

    Secondary: Response defined as Subject MAS rating 0 or 1 at rest at D120 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as Subject MAS rating 0 or 1 at rest at D120 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    76
    76
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D8 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D8 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    127
    127
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D8 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D8 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    124
    124
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D8 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D8 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    118
    118
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D30 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D30 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    126
    126
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D30 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D30 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    125
    125
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D30 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D30 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    120
    120
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D75 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D75 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    110
    110
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D75 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D75 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    102
    102
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D75 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D75 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    95
    95
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D120 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D120 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    78
    78
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D120 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D120 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    63
    63
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D120 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at max. contraction at D120 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    61
    61
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D8 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D8 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    70
    70
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D8 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D8 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    92
    92
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D8 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D8 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    93
    93
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D30 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D30 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    72
    72
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D30 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D30 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    97
    97
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D30 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D30 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    96
    96
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D75 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D75 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    66
    66
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D75 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D75 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    82
    82
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D75 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D75 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    70
    70
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D120 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D120 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    48
    48
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D120 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D120 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    64
    64
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Investigator MAS rating at rest at D120 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Investigator MAS rating at rest at D120 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    50
    50
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D8 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D8 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    120
    120
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D8 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D8 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    124
    124
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D8 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D8 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    114
    114
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D30 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D30 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    120
    120
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D30 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D30 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    127
    127
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D30 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D30 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    111
    111
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D75 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D75 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    102
    102
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D75 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D75 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    99
    99
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D75 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D75 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    81
    81
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D120 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D120 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    68
    68
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D120 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D120 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    66
    66
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D120 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at max. contraction at D120 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    62
    62
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D8 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D8 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    87
    87
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D8 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D8 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    113
    113
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D8 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D8 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D8 after OLOEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    135
    135
    Units: Responders
    100
    100
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D30 (OLEX) for GFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D30 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    90
    90
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D30 (OLEX) for HFL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D30 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    117
    117
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D30 (OLEX) for LPL

    		 Close Top of page
    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D30 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    103
    103
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D75 (OLEX) for GFL

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    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D75 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    77
    77
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D75 (OLEX) for HFL

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    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D75 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    92
    92
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D75 (OLEX) for LPL

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    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D75 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D75 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    130
    130
    Units: Responders
    83
    83
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D120 (OLEX) for GFL

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    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D120 (OLEX) for GFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    61
    61
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D120 (OLEX) for HFL

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    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D120 (OLEX) for HFL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    71
    71
    No statistical analyses for this end point

    Secondary: Response defined as improvement of at least one point in Subject MAS rating at rest at D120 (OLEX) for LPL

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    End point title
    		 Response defined as improvement of at least one point in Subject MAS rating at rest at D120 (OLEX) for LPL
    End point description
    End point type
    Secondary
    End point timeframe
    D120 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    134
    134
    Units: Responders
    66
    66
    No statistical analyses for this end point

    Secondary: Response defined as Investigator rating score of much improved (+2) or very much improved (+3) at D30 (OLEX) for the overall appearance of the upper face according to Global impression of Change Scale (GICS)

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    End point title
    		 Response defined as Investigator rating score of much improved (+2) or very much improved (+3) at D30 (OLEX) for the overall appearance of the upper face according to Global impression of Change Scale (GICS)
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    120
    120
    No statistical analyses for this end point

    Secondary: Response defined as Subject rating score of much improved (+2) or very much improved (+3) at D30 (OLEX) for the overall appearance of the upper face according to Global impression of Change Scale (GICS)

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    End point title
    		 Response defined as Subject rating score of much improved (+2) or very much improved (+3) at D30 (OLEX) for the overall appearance of the upper face according to Global impression of Change Scale (GICS)
    End point description
    End point type
    Secondary
    End point timeframe
    D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    136
    136
    Units: Responders
    114
    114
    No statistical analyses for this end point

    Secondary: Onset of effect by D8 (OLEX) for GFL as reported by Subject according to diary

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    End point title
    		 Onset of effect by D8 (OLEX) for GFL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Up to D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    139
    139
    Units: Onsets
    131
    131
    No statistical analyses for this end point

    Secondary: Onset of effect by D8 (OLEX) for HFL as reported by Subject according to diary

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    End point title
    		 Onset of effect by D8 (OLEX) for HFL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Up to D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    139
    139
    Units: Onsets
    133
    133
    No statistical analyses for this end point

    Secondary: Onset of effect by D8 (OLEX) for left LPL as reported by Subject according to diary

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    End point title
    		 Onset of effect by D8 (OLEX) for left LPL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Up to D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    139
    139
    Units: Onsets
    121
    121
    No statistical analyses for this end point

    Secondary: Onset of effect by D8 (OLEX) for right LPL as reported by Subject according to diary

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    End point title
    		 Onset of effect by D8 (OLEX) for right LPL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Up to D8 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    139
    139
    Units: Onsets
    123
    123
    No statistical analyses for this end point

    Secondary: Onset of effect between D8 and Day 30 (OLEX) for GFL as reported by Subject according to diary

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    End point title
    		 Onset of effect between D8 and Day 30 (OLEX) for GFL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Between D8 and D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    139
    139
    Units: Onsets
    3
    3
    No statistical analyses for this end point

    Secondary: Onset of effect between D8 and Day 30 (OLEX) for HFL as reported by Subject according to diary

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    End point title
    		 Onset of effect between D8 and Day 30 (OLEX) for HFL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Between D8 and D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    139
    139
    Units: Onsets
    3
    3
    No statistical analyses for this end point

    Secondary: Onset of effect between D8 and Day 30 (OLEX) for left LPL as reported by Subject according to diary

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    End point title
    		 Onset of effect between D8 and Day 30 (OLEX) for left LPL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Between D8 and D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    139
    139
    Units: Onsets
    8
    8
    No statistical analyses for this end point

    Secondary: Onset of effect between D8 and Day 30 (OLEX) for right LPL as reported by Subject according to diary

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    End point title
    		 Onset of effect between D8 and Day 30 (OLEX) for right LPL as reported by Subject according to diary
    End point description
    End point type
    Secondary
    End point timeframe
    Between D8 and D30 after OLEX injection
    End point values
    		 NT 201 Full Analysis Set (FAS)
    Number of subjects analysed
    139
    139
    Units: Onsets
    6
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the timepoint of first injection until 120 +/- 7 days after last administration of injection.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    NT 201 (MP)
    Reporting group description
    		 -

    Reporting group title
    Placebo (MP)
    Reporting group description
    		 -

    Reporting group title
    OLEX total subjects treated with NT 201
    Reporting group description
    		 -

    Serious adverse events
    		 NT 201 (MP) Placebo (MP) OLEX total subjects treated with NT 201
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 105 (3.81%)
    2 / 51 (3.92%)
    1 / 139 (0.72%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 51 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 51 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Accident
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 51 (1.96%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 51 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Bunion operation
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 51 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myomectomy
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 51 (1.96%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 51 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 51 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal prolapse
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 51 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 51 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 51 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary tract disorder
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 51 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 51 (0.00%)
    1 / 139 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Foot deformity
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 51 (0.00%)
    0 / 139 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 NT 201 (MP) Placebo (MP) OLEX total subjects treated with NT 201
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 105 (61.90%)
    28 / 51 (54.90%)
    64 / 139 (46.04%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    24 / 105 (22.86%)
    1 / 51 (1.96%)
    13 / 139 (9.35%)
         occurrences all number
    27
    2
    14
    General disorders and administration site conditions
    Injection site haematoma
         subjects affected / exposed
    4 / 105 (3.81%)
    3 / 51 (5.88%)
    10 / 139 (7.19%)
         occurrences all number
    5
    5
    11
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 105 (0.95%)
    2 / 51 (3.92%)
    2 / 139 (1.44%)
         occurrences all number
    1
    2
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    20 / 105 (19.05%)
    10 / 51 (19.61%)
    12 / 139 (8.63%)
         occurrences all number
    25
    12
    12
    Influenza
         subjects affected / exposed
    4 / 105 (3.81%)
    1 / 51 (1.96%)
    4 / 139 (2.88%)
         occurrences all number
    4
    1
    5
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 105 (1.90%)
    2 / 51 (3.92%)
    1 / 139 (0.72%)
         occurrences all number
    2
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jul 2012
    Since the release of the initial protocol on 05-APR-2012, one protocol amendment was issued prior to start of enrollment on 27-JUL-2012. The main change to the protocol and the rationale for amended clinical study protocol version 2.0 (issued 18-JUL-2012) was as follows: • The event ‘dry eye’ was added as an indication specific AESI for close monitoring as recommended by the German Health Authority (BfArM).

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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