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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Parallel, 26-Week, Phase 3 Study of 2 Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo as an Adjunctive Pro-cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy

    Summary
    EudraCT number
    		 2012-003209-92
    Trial protocol
    		 GB   IT   PL  
    Global end of trial date
    14 Dec 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Jan 2017
    First version publication date
    31 Dec 2016
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    The endpoint "Columbia Suicide-Severity Rating Scale (C-SSRS) (Day 182)" should be listed as a primary endpoint.

    Trial information

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    Trial identification
    Sponsor protocol code
    EVP-6124-016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND Number: 076939
    Sponsors
    Sponsor organisation name
    Forum Pharmaceuticals Inc.
    Sponsor organisation address
    225 Second Avenue, Waltham, MA, United States, 02451
    Public contact
    SSU & Regulatory Lead, INC Research , valerie.desaedeleer@incresearch.com
    Scientific contact
    SSU & Regulatory Lead, INC Research , valerie.desaedeleer@incresearch.com
    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
    12 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study are to assess the safety and the efficacy of 2 doses of once daily EVP-6124 tablets (1 and 2 mg) as an adjunctive pro-cognitive treatment, versus placebo, when added to chronic, stable, atypical antipsychotic therapy in subjects with schizophrenia. Safety will be determined by clinical and laboratory safety assessments. Efficacy will be determined by cognitive function as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS™) Consensus Cognitive Battery (MCCB™) Neurocognitive Composite Score, and by clinical function as measured by the interview-based Schizophrenia Cognition Rating Scale (SCoRS).
    Protection of trial subjects
    Measures to minimize pain and discomfort secondary to phlebotomy were used on an as-needed basis. As there were no other invasive measures in this study, additional interventions were not needed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Dec 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
    Poland: 19
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Italy: 21
    Country: Number of subjects enrolled
    Argentina: 26
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Colombia: 51
    Country: Number of subjects enrolled
    Mexico: 19
    Country: Number of subjects enrolled
    Romania: 43
    Country: Number of subjects enrolled
    Russian Federation: 73
    Country: Number of subjects enrolled
    Ukraine: 147
    Country: Number of subjects enrolled
    United States: 354
    Worldwide total number of subjects
    766
    EEA total number of subjects
    93
    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)
    766
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects will be screened for eligibility within 28 days of entry into the single-blind placebo Run-in Period. On Day -14 subjects will be dispensed a 32-day supply of single-blind, placebo study medication.

    Pre-assignment period milestones
    Number of subjects started
    		 1146 [1]
    Intermediate milestone: Number of subjects
    Entered Run-In: 818
    Number of subjects completed
    		 766

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen Fails Prior to Run-In: 329
    Reason: Number of subjects
    		 Withdrawn Prior to Randomization: 51
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The worldwide number corresponds to the number of patients randomized (766) and not to the number of patients screened (1146).
    Period 1
    Period 1 title
    Double-blind period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EVP-6124, 1 mg
    Arm description
    		 Eligible subjects will be randomized in a 1:1:1 allocation to 1 of 3 double-blind treatment groups: once daily EVP-6124 tablets (1 or 2 mg) or placebo for 26 weeks (Days 1 to 182).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Encenicline
    Investigational medicinal product code
    EVP-6124
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects will be instructed to take 1 tablet of study medication once daily at the same time each day, preferably between 8 to 10 AM, with or without food, and with an adequate amount of water.

    Arm title
    		 EVP-6124, 2 mg
    Arm description
    		 Eligible subjects will be randomized in a 1:1:1 allocation to 1 of 3 double-blind treatment groups: once daily EVP-6124 tablets (1 or 2 mg) or placebo for 26 weeks (Days 1 to 182).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Encenicline
    Investigational medicinal product code
    EVP-6124
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects will be instructed to take 1 tablet of study medication once daily at the same time each day, preferably between 8 to 10 AM, with or without food, and with an adequate amount of water.

    Arm title
    		 Placebo
    Arm description
    		 Eligible subjects will be randomized in a 1:1:1 allocation to 1 of 3 double-blind treatment groups: once daily EVP-6124 tablets (1 or 2 mg) or placebo for 26 weeks (Days 1 to 182).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects will be instructed to take 1 tablet of study medication once daily at the same time each day, preferably between 8 to 10 AM, with or without food, and with an adequate amount of water.

    Number of subjects in period 1
    		EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Started
    258
    254
    254
    Completed
    205
    193
    200
    Not completed
    53
    61
    54
         Physician decision
    1
    1
    1
         Consent withdrawn by subject
    19
    27
    19
         Medication prohibited by protocol
    1
    1
    -
         Adverse event, non-fatal
    14
    9
    13
         Other
    1
    2
    2
         Substance Abuse
    6
    7
    3
         Lost to follow-up
    8
    7
    13
         Protocol deviation
    3
    7
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EVP-6124, 1 mg
    Reporting group description
    		 Eligible subjects will be randomized in a 1:1:1 allocation to 1 of 3 double-blind treatment groups: once daily EVP-6124 tablets (1 or 2 mg) or placebo for 26 weeks (Days 1 to 182).

    Reporting group title
    EVP-6124, 2 mg
    Reporting group description
    		 Eligible subjects will be randomized in a 1:1:1 allocation to 1 of 3 double-blind treatment groups: once daily EVP-6124 tablets (1 or 2 mg) or placebo for 26 weeks (Days 1 to 182).

    Reporting group title
    Placebo
    Reporting group description
    		 Eligible subjects will be randomized in a 1:1:1 allocation to 1 of 3 double-blind treatment groups: once daily EVP-6124 tablets (1 or 2 mg) or placebo for 26 weeks (Days 1 to 182).

    Reporting group values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo Total
    Number of subjects
    		 258 254 254 766
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 258 254 254 766
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 36.6 (18 to 50) 36.6 (18 to 50) 35.9 (19 to 50) -
    Gender categorical
    Units: Subjects
        Female
    		 99 74 100 273
        Male
    		 159 180 154 493

    End points

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    End points reporting groups
    Reporting group title
    EVP-6124, 1 mg
    Reporting group description
    		 Eligible subjects will be randomized in a 1:1:1 allocation to 1 of 3 double-blind treatment groups: once daily EVP-6124 tablets (1 or 2 mg) or placebo for 26 weeks (Days 1 to 182).

    Reporting group title
    EVP-6124, 2 mg
    Reporting group description
    		 Eligible subjects will be randomized in a 1:1:1 allocation to 1 of 3 double-blind treatment groups: once daily EVP-6124 tablets (1 or 2 mg) or placebo for 26 weeks (Days 1 to 182).

    Reporting group title
    Placebo
    Reporting group description
    		 Eligible subjects will be randomized in a 1:1:1 allocation to 1 of 3 double-blind treatment groups: once daily EVP-6124 tablets (1 or 2 mg) or placebo for 26 weeks (Days 1 to 182).

    Primary: MATRICS Consensus Cognition Battery (MCCB) Neurocognitive Composite T-Scores with imputation of missing components (Change from baseline)

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    End point title
    		 MATRICS Consensus Cognition Battery (MCCB) Neurocognitive Composite T-Scores with imputation of missing components (Change from baseline)
    End point description
    End point type
    Primary
    End point timeframe
    Day -14 (training and practice) and testing on Days 1 (pre-dose), 28, 56, 84, and 182.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    255
    251
    250
    Units: n/a
        arithmetic mean (standard error)
    3.4 ( 0.42 )
    3.4 ( 0.46 )
    3 ( 0.41 )
    Statistical analysis title
    		 Hochberg method adjustment
    Comparison groups
    EVP-6124, 1 mg v EVP-6124, 2 mg v Placebo
    Number of subjects included in analysis
    756
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hochberg method adjustment
    Confidence interval

    Primary: Schizophrenia Cognition Rating Scale (SCoRS) Total Scores (Change from baseline)

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    End point title
    		 Schizophrenia Cognition Rating Scale (SCoRS) Total Scores (Change from baseline)
    End point description
    End point type
    Primary
    End point timeframe
    On Day -14 (training and practice) and testing on Days 1 (pre-dose), 28, 56, 84, and 182
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    255
    251
    250
    Units: n/a
        arithmetic mean (full range (min-max))
    -3.3 (-21 to 30)
    -3.7 (-23 to 27)
    -3.4 (-28 to 17)
    Statistical analysis title
    		 Hochberg method adjustment
    Comparison groups
    EVP-6124, 1 mg v EVP-6124, 2 mg v Placebo
    Number of subjects included in analysis
    756
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hochberg method adjustment
    Confidence interval

    Primary: MATRICS Consensus Cognition Battery (MCCB) Neurocognitive Composite T-scores without imputation of missing components (Change from baseline)

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    End point title
    		 MATRICS Consensus Cognition Battery (MCCB) Neurocognitive Composite T-scores without imputation of missing components (Change from baseline)
    End point description
    End point type
    Primary
    End point timeframe
    On Day -14 (training and practice) and testing on Days 1 (pre-dose), 28, 56, 84, and 182.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    255
    251
    250
    Units: n/a
        arithmetic mean (full range (min-max))
    3.5 (-15 to 20)
    3.7 (-12 to 23)
    2.9 (-14 to 19)
    Statistical analysis title
    		 Hochberg method adjustment
    Comparison groups
    EVP-6124, 1 mg v EVP-6124, 2 mg v Placebo
    Number of subjects included in analysis
    756
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hochberg method adjustment
    Confidence interval

    Primary: Summary of Treatment-Emergent Adverse Events (TEAE)

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    End point title
    		 Summary of Treatment-Emergent Adverse Events (TEAE) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Any time after the subject signs the ICF through the follow-up period of the study (Day 182, 189, or ET, as applicable).
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: Subjects with any TEAE
    127
    127
    148
    No statistical analyses for this end point

    Primary: Basophils (Change from baseline)

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    End point title
    		 Basophils (Change from baseline) [2]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: 10^9/L
        arithmetic mean (full range (min-max))
    0.003 (-0.06 to 0.12)
    0 (-0.11 to 0.07)
    -0.002 (-0.11 to 0.04)
    No statistical analyses for this end point

    Primary: Basophils/Leukocytes (Change from baseline)

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    End point title
    		 Basophils/Leukocytes (Change from baseline) [3]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: percent
        arithmetic mean (full range (min-max))
    0 (-1 to 1)
    0 (-1 to 1)
    0 (-2 to 1)
    No statistical analyses for this end point

    Primary: Eosinophils (Change from baseline)

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    End point title
    		 Eosinophils (Change from baseline) [4]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: 10^9/L
        arithmetic mean (full range (min-max))
    -0.01 (-0.93 to 0.45)
    -0.001 (-0.34 to 0.33)
    0.001 (-0.52 to 0.58)
    No statistical analyses for this end point

    Primary: Eosinophils/Leukocytes (Change from baseline)

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    End point title
    		 Eosinophils/Leukocytes (Change from baseline) [5]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: percent
        arithmetic mean (full range (min-max))
    -0.2 (-12 to 6)
    -0.1 (-5 to 7)
    0 (-11 to 8)
    No statistical analyses for this end point

    Primary: Erythrocytes (Change from baseline)

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    End point title
    		 Erythrocytes (Change from baseline) [6]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: 10^12/L
        arithmetic mean (full range (min-max))
    0.008 (-0.83 to 1.82)
    0.001 (-0.77 to 1.16)
    0.025 (-0.98 to 1.07)
    No statistical analyses for this end point

    Primary: Hematocrit (Change from baseline)

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    End point title
    		 Hematocrit (Change from baseline) [7]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: percent
        arithmetic mean (full range (min-max))
    0.11 (-9.8 to 8.8)
    0.21 (-10.3 to 11.2)
    0.24 (-8.3 to 7)
    No statistical analyses for this end point

    Primary: Hemoglobin (Change from baseline)

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    End point title
    		 Hemoglobin (Change from baseline) [8]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: g/dL
        arithmetic mean (full range (min-max))
    -0.04 (-3.6 to 2.4)
    -0.03 (-2.5 to 3.8)
    -0.01 (-2.7 to 2.3)
    No statistical analyses for this end point

    Primary: Leukocytes (Change from baseline)

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    End point title
    		 Leukocytes (Change from baseline) [9]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: 10^9/L
        arithmetic mean (full range (min-max))
    0 (-6.8 to 5.67)
    0.255 (-6.1 to 9.9)
    -0.063 (-8.1 to 8.6)
    No statistical analyses for this end point

    Primary: Lymphocytes (Change from baseline)

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    End point title
    		 Lymphocytes (Change from baseline) [10]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: 10^9/L
        arithmetic mean (full range (min-max))
    -0.019 (-1.96 to 1.75)
    0.028 (-1.54 to 1.96)
    -0.03 (-2.33 to 2.3)
    No statistical analyses for this end point

    Primary: Lymphocytes/Leukocytes (Change from baseline)

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    End point title
    		 Lymphocytes/Leukocytes (Change from baseline) [11]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: percent
        arithmetic mean (full range (min-max))
    -0.7 (-26 to 24)
    -0.6 (-25 to 18)
    -0.3 (-30 to 21)
    No statistical analyses for this end point

    Primary: Monocytes (Change from baseline)

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    End point title
    		 Monocytes (Change from baseline) [12]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: 10^9/L
        arithmetic mean (full range (min-max))
    0.006 (-1 to 0.69)
    0.018 (-0.62 to 0.81)
    -0.018 (-0.89 to 0.73)
    No statistical analyses for this end point

    Primary: Monocytes/Leukocytes (Change from baseline)

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    End point title
    		 Monocytes/Leukocytes (Change from baseline) [13]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: percent
        arithmetic mean (full range (min-max))
    0.1 (-10 to 15)
    -0.1 (-10 to 5)
    -0.3 (-10 to 12)
    No statistical analyses for this end point

    Primary: Neutrophils (Change from baseline)

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    End point title
    		 Neutrophils (Change from baseline) [14]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: 10^9/L
        arithmetic mean (full range (min-max))
    0.021 (-7.02 to 4.78)
    0.214 (-4.48 to 9.65)
    -0.009 (-6.72 to 7.86)
    No statistical analyses for this end point

    Primary: Neutrophils/Leukocytes (Change from baseline)

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    End point title
    		 Neutrophils/Leukocytes (Change from baseline) [15]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: percent
        arithmetic mean (full range (min-max))
    0.8 (-29 to 32)
    0.7 (-25 to 35)
    0.7 (-22 to 39)
    No statistical analyses for this end point

    Primary: Platelets (Change from baseline)

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    End point title
    		 Platelets (Change from baseline) [16]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: 10^9/L
        arithmetic mean (full range (min-max))
    0.2 (-195 to 68)
    0.3 (-198 to 159)
    4 (-114 to 84)
    No statistical analyses for this end point

    Primary: Alanine Aminotransferase (Change from baseline)

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    End point title
    		 Alanine Aminotransferase (Change from baseline) [17]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: IU/L
        arithmetic mean (full range (min-max))
    1.1 (-87 to 109)
    -1 (-99 to 57)
    -2.4 (-185 to 100)
    No statistical analyses for this end point

    Primary: Albumin (Change from baseline)

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    End point title
    		 Albumin (Change from baseline) [18]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: g/dL
        arithmetic mean (full range (min-max))
    -0.02 (-0.6 to 0.8)
    -0.03 (-0.8 to 0.7)
    0.02 (-1.1 to 1)
    No statistical analyses for this end point

    Primary: Alkaline Phosphatase (Change from baseline)

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    End point title
    		 Alkaline Phosphatase (Change from baseline) [19]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: IU/L
        arithmetic mean (full range (min-max))
    -0.5 (-51 to 69)
    -3.8 (-62 to 48)
    -0.8 (-136 to 62)
    No statistical analyses for this end point

    Primary: Aspartate Aminotransferase (Change from baseline)

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    End point title
    		 Aspartate Aminotransferase (Change from baseline) [20]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: IU/L
        arithmetic mean (full range (min-max))
    0.5 (-51 to 60)
    -0.7 (-71 to 91)
    -1.2 (-97 to 78)
    No statistical analyses for this end point

    Primary: Bicarbonate (Change from baseline)

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    End point title
    		 Bicarbonate (Change from baseline) [21]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: mEq/L
        arithmetic mean (full range (min-max))
    -0.4 (-10 to 8)
    -0.5 (-8 to 5)
    -0.5 (-10 to 6)
    No statistical analyses for this end point

    Primary: Bilirubin (Change from baseline)

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    End point title
    		 Bilirubin (Change from baseline) [22]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: mg/dL
        arithmetic mean (full range (min-max))
    -0.01 (-0.7 to 1.3)
    0 (-0.8 to 1)
    -0.01 (-1 to 0.7)
    No statistical analyses for this end point

    Primary: Blood Urea Nitrogen (Change from baseline)

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    End point title
    		 Blood Urea Nitrogen (Change from baseline) [23]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: mg/dL
        arithmetic mean (full range (min-max))
    -0.5 (-11 to 11)
    0 (-14 to 12)
    0.2 (-9 to 13)
    No statistical analyses for this end point

    Primary: Calcium (Change from baseline)

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    End point title
    		 Calcium (Change from baseline) [24]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: mg/dL
        arithmetic mean (full range (min-max))
    -0.01 (-1 to 1.2)
    -0.04 (-1 to 1.3)
    0.01 (-1.5 to 1.2)
    No statistical analyses for this end point

    Primary: Chloride (Change from baseline)

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    End point title
    		 Chloride (Change from baseline) [25]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: mEq/L
        arithmetic mean (full range (min-max))
    -0.4 (-9 to 7)
    -0.2 (-36 to 7)
    -0.5 (-7 to 11)
    No statistical analyses for this end point

    Primary: Creatine Phosphokinase (Change from baseline)

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    End point title
    		 Creatine Phosphokinase (Change from baseline) [26]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: IU/L
        arithmetic mean (full range (min-max))
    -5.1 (-1561 to 968)
    -7.8 (-2828 to 3159)
    -22.1 (-4919 to 1616)
    No statistical analyses for this end point

    Primary: Creatinine (Change from baseline)

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    End point title
    		 Creatinine (Change from baseline) [27]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: mg/dL
        arithmetic mean (full range (min-max))
    0.008 (-0.39 to 0.4)
    -0.001 (-0.37 to 0.4)
    -0.014 (-0.24 to 0.19)
    No statistical analyses for this end point

    Primary: Gamma Glutamyl Transferase (Change from baseline)

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    End point title
    		 Gamma Glutamyl Transferase (Change from baseline) [28]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: IU/L
        arithmetic mean (full range (min-max))
    1.2 (-212 to 92)
    0.5 (-62 to 46)
    -2.2 (-781 to 259)
    No statistical analyses for this end point

    Primary: Glucose (Change from baseline)

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    End point title
    		 Glucose (Change from baseline) [29]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: mg/dL
        arithmetic mean (full range (min-max))
    0.2 (-164 to 65)
    1.6 (-88 to 106)
    4.5 (-50 to 209)
    No statistical analyses for this end point

    Primary: Magnesium (Change from baseline)

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    End point title
    		 Magnesium (Change from baseline) [30]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: mg/dL
        arithmetic mean (full range (min-max))
    0.01 (-0.5 to 1.8)
    -0.02 (-0.5 to 0.4)
    -0.02 (-0.7 to 0.3)
    No statistical analyses for this end point

    Primary: Phosphate (Change from baseline)

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    End point title
    		 Phosphate (Change from baseline) [31]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: mg/dL
        arithmetic mean (full range (min-max))
    0.02 (-1.8 to 2.4)
    -0.06 (-1.5 to 1.9)
    0 (-1.6 to 2.5)
    No statistical analyses for this end point

    Primary: Potassium (Change from baseline)

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    End point title
    		 Potassium (Change from baseline) [32]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: mEq/L
        arithmetic mean (full range (min-max))
    0.05 (-1.1 to 1.4)
    0.01 (-1.4 to 1)
    0.02 (-1.4 to 1.1)
    No statistical analyses for this end point

    Primary: Protein (Change from baseline)

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    End point title
    		 Protein (Change from baseline) [33]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: g/dL
        arithmetic mean (full range (min-max))
    -0.05 (-1.2 to 1.1)
    -0.11 (-1.5 to 0.9)
    -0.01 (-1.9 to 1.9)
    No statistical analyses for this end point

    Primary: Sodium (Change from baseline)

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    End point title
    		 Sodium (Change from baseline) [34]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: mEq/L
        arithmetic mean (full range (min-max))
    0 (-10 to 7)
    0.3 (-18 to 9)
    0 (-6 to 9)
    No statistical analyses for this end point

    Primary: Urate (Change from baseline)

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    End point title
    		 Urate (Change from baseline) [35]
    End point description
    End point type
    Primary
    End point timeframe
    The non-fasting laboratory tests will be performed at the screening visit and on Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: mg/dL
        arithmetic mean (full range (min-max))
    0.05 (-2.8 to 2.6)
    0.06 (-3.5 to 3.3)
    0.05 (-3.2 to 3.8)
    No statistical analyses for this end point

    Primary: Systolic Blood Pressure (Change from baseline)

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    End point title
    		 Systolic Blood Pressure (Change from baseline) [36]
    End point description
    End point type
    Primary
    End point timeframe
    At the screening visit, on Day 1 pre-dose and within 3 hours post-dose, and on Days 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: mmHg
        arithmetic mean (full range (min-max))
    0.5 (-35 to 40)
    0.4 (-22 to 31)
    1.9 (-23 to 38)
    No statistical analyses for this end point

    Primary: Diastolic Blood Pressure (Change from baseline)

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    End point title
    		 Diastolic Blood Pressure (Change from baseline) [37]
    End point description
    End point type
    Primary
    End point timeframe
    At the screening visit, on Day 1 pre-dose and within 3 hours post-dose, and on Days 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: mmHg
        arithmetic mean (full range (min-max))
    0 (-20 to 25)
    -0.2 (-23 to 26)
    0.7 (-17 to 28)
    No statistical analyses for this end point

    Primary: Pulse Rate (Change from baseline)

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    End point title
    		 Pulse Rate (Change from baseline) [38]
    End point description
    End point type
    Primary
    End point timeframe
    At the screening visit, on Day 1 pre-dose and within 3 hours post-dose, and on Days 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: BEATS/MIN
        arithmetic mean (full range (min-max))
    -1 (-29 to 50)
    1.3 (-23 to 30)
    0.2 (-25 to 37)
    No statistical analyses for this end point

    Primary: Respiratory Rate (Change from baseline)

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    End point title
    		 Respiratory Rate (Change from baseline) [39]
    End point description
    End point type
    Primary
    End point timeframe
    At the screening visit, on Day 1 pre-dose and within 3 hours post-dose, and on Days 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: BREATHS/MIN
        arithmetic mean (full range (min-max))
    -0.1 (-5 to 6)
    0.2 (-4 to 8)
    0.1 (-13 to 4)
    No statistical analyses for this end point

    Primary: Temperature (Change from baseline)

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    End point title
    		 Temperature (Change from baseline) [40]
    End point description
    End point type
    Primary
    End point timeframe
    At the screening visit, on Day 1 pre-dose and within 3 hours post-dose, and on Days 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: Celsius
        arithmetic mean (full range (min-max))
    0 (-1.1 to 1.2)
    0.01 (-1 to 1)
    -0.03 (-1 to 1)
    No statistical analyses for this end point

    Primary: Weight (Change from baseline)

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    End point title
    		 Weight (Change from baseline) [41]
    End point description
    End point type
    Primary
    End point timeframe
    On Day 1 (pre-dose) and on Days 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: kg
        arithmetic mean (full range (min-max))
    0.31 (-10.3 to 17.1)
    0.28 (-12.1 to 12)
    0.53 (-11.6 to 19.5)
    No statistical analyses for this end point

    Primary: Heart Rate (Change from baseline)

    		 Close Top of page
    End point title
    		 Heart Rate (Change from baseline) [42]
    End point description
    End point type
    Primary
    End point timeframe
    At screening visit, Day 1 pre-dose and within 3 hours post-dose, and on Days 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: BEATS/MIN
        arithmetic mean (full range (min-max))
    0.3 (-35 to 50)
    2 (-19 to 50)
    0.8 (-28 to 46)
    No statistical analyses for this end point

    Primary: QT Duration (Change from baseline)

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    End point title
    		 QT Duration (Change from baseline) [43]
    End point description
    End point type
    Primary
    End point timeframe
    At screening visit, Day 1 pre-dose and within 3 hours post-dose, and on Days 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: msec
        arithmetic mean (full range (min-max))
    -1.2 (-72 to 65)
    -2.6 (-58 to 69)
    -0.8 (-86 to 58)
    No statistical analyses for this end point

    Primary: QTcB - Bazett's Correction Formula (Change from baseline)

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    End point title
    		 QTcB - Bazett's Correction Formula (Change from baseline) [44]
    End point description
    End point type
    Primary
    End point timeframe
    At screening visit, Day 1 pre-dose and within 3 hours post-dose, and on Days 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [44] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: msec
        arithmetic mean (full range (min-max))
    0.1 (-68 to 53)
    2.4 (-48 to 70)
    1.3 (-64 to 50)
    No statistical analyses for this end point

    Primary: QTcF - Fridericia's Correction Formula (Change from baseline)

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    End point title
    		 QTcF - Fridericia's Correction Formula (Change from baseline) [45]
    End point description
    End point type
    Primary
    End point timeframe
    At screening visit, Day 1 pre-dose and within 3 hours post-dose, and on Days 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: msec
        arithmetic mean (full range (min-max))
    -0.3 (-61 to 42)
    0.6 (-37 to 43)
    0.6 (-55 to 51)
    No statistical analyses for this end point

    Primary: QRS Duration (Change from baseline)

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    End point title
    		 QRS Duration (Change from baseline) [46]
    End point description
    End point type
    Primary
    End point timeframe
    At screening visit, Day 1 pre-dose and within 3 hours post-dose, and on Days 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: msec
        arithmetic mean (full range (min-max))
    -0.5 (-19 to 20)
    0.6 (-15 to 18)
    -0.4 (-69 to 24)
    No statistical analyses for this end point

    Primary: PR Duration (Change from baseline)

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    End point title
    		 PR Duration (Change from baseline) [47]
    End point description
    End point type
    Primary
    End point timeframe
    At screening visit, Day 1 pre-dose and within 3 hours post-dose, and on Days 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: msec
        arithmetic mean (full range (min-max))
    -1.2 (-83 to 41)
    -1.6 (-55 to 39)
    0.2 (-30 to 48)
    No statistical analyses for this end point

    Primary: Calgary Depression Severity in Schizophrenia (CDSS) (Day 182)

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    End point title
    		 Calgary Depression Severity in Schizophrenia (CDSS) (Day 182) [48]
    End point description
    End point type
    Primary
    End point timeframe
    Screening visit, Day 1 (Pre-dose), Day 182 and on ET.
    Notes
    [48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: n/a
        arithmetic mean (full range (min-max))
    1.2 (0 to 16)
    1 (0 to 10)
    1.2 (0 to 21)
    No statistical analyses for this end point

    Primary: Columbia Suicide-Severity Rating Scale (C-SSRS) (Day 182)

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    End point title
    		 Columbia Suicide-Severity Rating Scale (C-SSRS) (Day 182) [49]
    End point description
    End point type
    Primary
    End point timeframe
    Screening, Days 1 (pre-dose), 14 (telephone call), 28, 56, 84, 112, 140, and 182 (± 2 days) or early termination.
    Notes
    [49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: Subjects with suicidal behavior/ideation
    1
    0
    1
    No statistical analyses for this end point

    Primary: Simpson-Angus Total Scores (SAS) (Change from baseline)

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    End point title
    		 Simpson-Angus Total Scores (SAS) (Change from baseline) [50]
    End point description
    End point type
    Primary
    End point timeframe
    Screening, Days 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: n/a
        arithmetic mean (full range (min-max))
    0 (-4 to 7)
    -0.2 (-5 to 2)
    -0.1 (-3 to 4)
    No statistical analyses for this end point

    Primary: Positive and Negative Syndrome Scale (PANSS) Positive Symptom Scores (Change from baseline)

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    End point title
    		 Positive and Negative Syndrome Scale (PANSS) Positive Symptom Scores (Change from baseline) [51]
    End point description
    End point type
    Primary
    End point timeframe
    Days -14, 1 (pre-dose), and 28, 56, 84, 112, 140, and 182.
    Notes
    [51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical tests were not performed on safety parameters.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    258
    254
    254
    Units: n/a
        arithmetic mean (full range (min-max))
    -1.1 (-12 to 15)
    -1.3 (-10 to 21)
    -1.3 (-14 to 10)
    No statistical analyses for this end point

    Secondary: Positive and Negative Syndrome Scale (PANSS) Negative Symptom Factor (Marder Factor) (Change from baseline)

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    End point title
    		 Positive and Negative Syndrome Scale (PANSS) Negative Symptom Factor (Marder Factor) (Change from baseline)
    End point description
    End point type
    Secondary
    End point timeframe
    On Days -14, 1 (pre-dose), and 28, 56, 84, 112, 140, and 182.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    255
    251
    250
    Units: n/a
        arithmetic mean (full range (min-max))
    -1.9 (-14 to 11)
    -2.1 (-15 to 10)
    -1.7 (-15 to 9)
    Statistical analysis title
    		 Hochberg method adjustment
    Comparison groups
    EVP-6124, 2 mg v EVP-6124, 1 mg v Placebo
    Number of subjects included in analysis
    756
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hochberg method adjustment
    Confidence interval

    Secondary: MATRICS Consensus Cognition Battery (MCCB) Overall Composite T-Scores with imputation of missing components (Change from baseline)

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    End point title
    		 MATRICS Consensus Cognition Battery (MCCB) Overall Composite T-Scores with imputation of missing components (Change from baseline)
    End point description
    End point type
    Secondary
    End point timeframe
    Day -14 (training and practice) and testing on Days 1 (pre-dose), 28, 56, 84, and 182.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    255
    251
    250
    Units: n/a
        arithmetic mean (standard error)
    2.9 ( 0.41 )
    2.9 ( 0.45 )
    2.8 ( 0.43 )
    No statistical analyses for this end point

    Secondary: MATRICS Consensus Cognition Battery (MCCB) Overall Composite T-Scores without imputation of missing components (Change from baseline)

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    End point title
    		 MATRICS Consensus Cognition Battery (MCCB) Overall Composite T-Scores without imputation of missing components (Change from baseline)
    End point description
    End point type
    Secondary
    End point timeframe
    Day -14 (training and practice) and testing on Days 1 (pre-dose), 28, 56, 84, and 182.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    255
    251
    250
    Units: n/a
        arithmetic mean (full range (min-max))
    3 (-15 to 15)
    3.3 (-13 to 26)
    2.8 (-18 to 17)
    No statistical analyses for this end point

    Secondary: Schizophrenia Cognition Rating Scale (SCoRS) global rating (Change from baseline)

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    End point title
    		 Schizophrenia Cognition Rating Scale (SCoRS) global rating (Change from baseline)
    End point description
    End point type
    Secondary
    End point timeframe
    On Day -14 (training and practice) and testing on Days 1 (pre-dose), 28, 56, 84, and 182
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    255
    251
    250
    Units: n/a
        arithmetic mean (full range (min-max))
    -0.7 (-5 to 4)
    -0.6 (-4 to 3)
    -0.8 (-4 to 4)
    No statistical analyses for this end point

    Secondary: Positive and Negative Syndrome Scale (PANSS) Negative Symptom Score (Change from baseline)

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    End point title
    		 Positive and Negative Syndrome Scale (PANSS) Negative Symptom Score (Change from baseline)
    End point description
    End point type
    Secondary
    End point timeframe
    On Days -14, 1 (pre-dose), and 28, 56, 84, 112, 140, and 182.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    255
    251
    250
    Units: n/a
        arithmetic mean (full range (min-max))
    -1.8 (-12 to 10)
    -2 (-14 to 10)
    -1.5 (-11 to 12)
    No statistical analyses for this end point

    Secondary: Clinical Global Impression – Severity scale (CGI-S) (Day 182)

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    End point title
    		 Clinical Global Impression – Severity scale (CGI-S) (Day 182)
    End point description
    End point type
    Secondary
    End point timeframe
    On Days 1 (predose, baseline), and 28, 56, 84, 112, 140, and 182.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    255
    251
    250
    Units: n/a
        arithmetic mean (full range (min-max))
    3.2 (1 to 5)
    3.2 (1 to 6)
    3.3 (1 to 5)
    No statistical analyses for this end point

    Secondary: Clinical Global Impression – Change scale (CGI-C) (Day 182)

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    End point title
    		 Clinical Global Impression – Change scale (CGI-C) (Day 182)
    End point description
    End point type
    Secondary
    End point timeframe
    Days 28, 56, 84, 112, 140, and 182
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Placebo
    Number of subjects analysed
    255
    251
    250
    Units: n/a
        arithmetic mean (full range (min-max))
    3.3 (1 to 6)
    3.3 (1 to 6)
    3.3 (1 to 6)
    No statistical analyses for this end point

    Other pre-specified: Concentration of EVP-6124 (Day 182)

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    End point title
    		 Concentration of EVP-6124 (Day 182) [52]
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The concentration of EVP-6124 was not reported in the placebo arm.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    255
    250
    Units: ng/mL
        arithmetic mean (full range (min-max))
    1.7286 (0 to 5.94)
    3.2306 (0 to 9.48)
    No statistical analyses for this end point

    Other pre-specified: Concentration of EVP-6124 N-oxide (Day 182)

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    End point title
    		 Concentration of EVP-6124 N-oxide (Day 182) [53]
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The concentration of EVP-6124 N-oxide was not reported in the placebo arm.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    255
    250
    Units: ng/mL
        arithmetic mean (full range (min-max))
    0.1752 (0 to 0.629)
    0.3242 (0 to 0.917)
    No statistical analyses for this end point

    Other pre-specified: Concentration of EVP-6124 Acid Metabolite (Day 182)

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    End point title
    		 Concentration of EVP-6124 Acid Metabolite (Day 182) [54]
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Day 1 (pre-dose), 28, 56, 84, 112, 140, and 182 (± 2 days) or ET.
    Notes
    [54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The concentration of EVP-6124 Acid Metabolite was not reported in the placebo arm.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    255
    250
    Units: ng/mL
        arithmetic mean (full range (min-max))
    0.2584 (0 to 0.942)
    0.4645 (0 to 2.58)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events observed at any time after the subject signs the informed consent through the follow-up period of the study (Day 182, 189, or ET, as applicable) are to be recorded.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    EVP-6124, 1 mg
    Reporting group description
    		 Eligible subjects will be randomized in a 1:1:1 allocation to 1 of 3 double-blind treatment groups: once daily EVP-6124 tablets (1 or 2 mg) or placebo for 26 weeks (Days 1 to 182).

    Reporting group title
    Placebo
    Reporting group description
    		 Eligible subjects will be randomized in a 1:1:1 allocation to 1 of 3 double-blind treatment groups: once daily EVP-6124 tablets (1 or 2 mg) or placebo for 26 weeks (Days 1 to 182).

    Reporting group title
    EVP-6124, 2 mg
    Reporting group description
    		 Eligible subjects will be randomized in a 1:1:1 allocation to 1 of 3 double-blind treatment groups: once daily EVP-6124 tablets (1 or 2 mg) or placebo for 26 weeks (Days 1 to 182).

    Serious adverse events
    		 EVP-6124, 1 mg Placebo EVP-6124, 2 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 258 (4.26%)
    7 / 254 (2.76%)
    7 / 254 (2.76%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    ECG signs of myocardial ischaemia
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychiatric decompensation
         subjects affected / exposed
    6 / 258 (2.33%)
    5 / 254 (1.97%)
    4 / 254 (1.57%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 7
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Substance abuse
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Stag horn calculus
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Dengue fever
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 EVP-6124, 1 mg Placebo EVP-6124, 2 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    127 / 258 (49.22%)
    148 / 254 (58.27%)
    127 / 254 (50.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 258 (1.55%)
    4 / 254 (1.57%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Hypotension
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 258 (1.16%)
    1 / 254 (0.39%)
    3 / 254 (1.18%)
         occurrences all number
    127
    148
    127
    Asthenia
         subjects affected / exposed
    2 / 258 (0.78%)
    3 / 254 (1.18%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 254 (0.39%)
    2 / 254 (0.79%)
         occurrences all number
    127
    148
    127
    Pyrexia
         subjects affected / exposed
    1 / 258 (0.39%)
    2 / 254 (0.79%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Oedema peripheral
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    2 / 254 (0.79%)
         occurrences all number
    127
    148
    127
    Chills
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Malaise
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Reproductive system and breast disorders
    Amenorrhoea
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    2 / 254 (0.79%)
         occurrences all number
    127
    148
    127
    Dysfunctional uterine bleeding
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Dysmenorrhoea
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Lactation disorder
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    1448
    127
    Menopausal symptoms
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Menstrual disorder
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Ovarian cyst
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 258 (0.39%)
    2 / 254 (0.79%)
    3 / 254 (1.18%)
         occurrences all number
    127
    148
    127
    Asthma
         subjects affected / exposed
    2 / 258 (0.78%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Nasal congestion
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 254 (0.39%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Wheezing
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 254 (0.39%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Sinus congestion
         subjects affected / exposed
    0 / 258 (0.00%)
    2 / 254 (0.79%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Dyspnoea
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Epistaxis
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Haemoptysis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Productive cough
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Respiratory disorder
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Respiratory tract congestion
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Sneezing
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Throat irritation
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Psychiatric disorders
    Psychiatric decompensation
         subjects affected / exposed
    10 / 258 (3.88%)
    9 / 254 (3.54%)
    9 / 254 (3.54%)
         occurrences all number
    127
    148
    127
    Insomnia
         subjects affected / exposed
    8 / 258 (3.10%)
    11 / 254 (4.33%)
    7 / 254 (2.76%)
         occurrences all number
    127
    148
    127
    Anxiety
         subjects affected / exposed
    9 / 258 (3.49%)
    5 / 254 (1.97%)
    8 / 254 (3.15%)
         occurrences all number
    127
    148
    127
    Irritability
         subjects affected / exposed
    3 / 258 (1.16%)
    4 / 254 (1.57%)
    3 / 254 (1.18%)
         occurrences all number
    127
    148
    127
    Depression
         subjects affected / exposed
    1 / 258 (0.39%)
    3 / 254 (1.18%)
    4 / 254 (1.57%)
         occurrences all number
    127
    148
    127
    Tension
         subjects affected / exposed
    3 / 258 (1.16%)
    1 / 254 (0.39%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Suicidal ideation
         subjects affected / exposed
    0 / 258 (0.00%)
    2 / 254 (0.79%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Agitation
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Depressed mood
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Panic attack
         subjects affected / exposed
    0 / 258 (0.00%)
    2 / 254 (0.79%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Psychotic disorder
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Schizophrenia
         subjects affected / exposed
    2 / 258 (0.78%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Sleep disorder
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Abnormal dreams
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Affect lability
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Confusional state
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Depressive symptom
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Disturbance in social behaviour
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Drug abuse
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Dysphoria
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Emotional disorder
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Hallucination
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Homicidal ideation
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Initial insomnia
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Middle insomnia
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Mood swings
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Somnambulism
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Substance abuse
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Suicide attempt
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Investigations
    Weight increased
         subjects affected / exposed
    6 / 258 (2.33%)
    10 / 254 (3.94%)
    6 / 254 (2.36%)
         occurrences all number
    127
    148
    127
    Blood creatine phosphokinase increased
         subjects affected / exposed
    4 / 258 (1.55%)
    12 / 254 (4.72%)
    5 / 254 (1.97%)
         occurrences all number
    127
    148
    127
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 258 (0.78%)
    5 / 254 (1.97%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 258 (0.78%)
    4 / 254 (1.57%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 258 (0.78%)
    3 / 254 (1.18%)
    2 / 254 (0.79%)
         occurrences all number
    127
    148
    127
    Weight decreased
         subjects affected / exposed
    3 / 258 (1.16%)
    0 / 254 (0.00%)
    4 / 254 (1.57%)
         occurrences all number
    127
    148
    127
    Blood pressure increased
         subjects affected / exposed
    0 / 258 (0.00%)
    2 / 254 (0.79%)
    2 / 254 (0.79%)
         occurrences all number
    127
    148
    127
    Blood creatinine increased
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Blood glucose increased
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Electrocardiogram T wave amplitude decreased
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Blood cholesterol increased
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Cardiac murmur
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Drug screen positive
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    ECG signs of myocardial ischaemia
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Electrocardiogram ST segment depression
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Electrocardiogram T wave inversion
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Haematocrit increased
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Haemoglobin decreased
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Haemoglobin increased
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Neutrophil count decreased
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Red blood cell count increased
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Red blood cells urine
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Urinary casts
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Urine leukocyte esterase positive
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    White blood cell count increased
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    White blood cells urine positive
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    2 / 258 (0.78%)
    4 / 254 (1.57%)
    3 / 254 (1.18%)
         occurrences all number
    127
    148
    127
    Laceration
         subjects affected / exposed
    0 / 258 (0.00%)
    2 / 254 (0.79%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Muscle strain
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    2 / 254 (0.79%)
         occurrences all number
    127
    148
    127
    Road traffic accident
         subjects affected / exposed
    0 / 258 (0.00%)
    2 / 254 (0.79%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Contusion
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Animal bite
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Ankle fracture
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Arthropod bite
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Back injury
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Burns second degree
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Craniocerebral injury
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Epicondylitis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Eye injury
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Foot fracture
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Hand fracture
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Head injury
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Hip fracture
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Human bite
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Joint dislocation
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Limb injury
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Lip injury
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Multiple injuries
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Scratch
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Skin abrasion
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Soft tissue injury
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Tooth fracture
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Palpitations
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Tachycardia
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Bradycardia
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Defect conduction intraventricular
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Myocardial infarction
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Tachycardia paroxysmal
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 258 (5.04%)
    15 / 254 (5.91%)
    18 / 254 (7.09%)
         occurrences all number
    127
    148
    127
    Dizziness
         subjects affected / exposed
    6 / 258 (2.33%)
    5 / 254 (1.97%)
    5 / 254 (1.97%)
         occurrences all number
    127
    148
    127
    Somnolence
         subjects affected / exposed
    3 / 258 (1.16%)
    1 / 254 (0.39%)
    6 / 254 (2.36%)
         occurrences all number
    127
    148
    127
    Tremor
         subjects affected / exposed
    3 / 258 (1.16%)
    4 / 254 (1.57%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Akathisia
         subjects affected / exposed
    2 / 258 (0.78%)
    2 / 254 (0.79%)
    2 / 254 (0.79%)
         occurrences all number
    127
    148
    127
    Paraesthesia
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 254 (0.39%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Extrapyramidal disorder
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Sciatica
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    2 / 254 (0.79%)
         occurrences all number
    127
    148
    127
    Sedation
         subjects affected / exposed
    0 / 258 (0.00%)
    2 / 254 (0.79%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Cognitive disorder
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Cogwheel rigidity
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Convulsion
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Cubital tunnel syndrome
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Drooling
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Dyskinesia
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Hypokinesia
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Loss of consciousness
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Parkinsonism
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Poor quality sleep
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Presyncope
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Psychomotor hyperactivity
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Radiculitis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 254 (0.39%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Neutropenia
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Eosinophilia
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Lymphadenopathy
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Polycythaemia
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    2 / 258 (0.78%)
    1 / 254 (0.39%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Ear discomfort
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Ear canal erythema
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 258 (0.00%)
    2 / 254 (0.79%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Blepharospasm
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Eye irritation
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Eye pain
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Visual acuity reduced
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Vitreous floaters
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    14 / 258 (5.43%)
    8 / 254 (3.15%)
    17 / 254 (6.69%)
         occurrences all number
    127
    148
    127
    Diarrhoea
         subjects affected / exposed
    2 / 258 (0.78%)
    8 / 254 (3.15%)
    6 / 254 (2.36%)
         occurrences all number
    127
    148
    127
    Dyspepsia
         subjects affected / exposed
    4 / 258 (1.55%)
    1 / 254 (0.39%)
    7 / 254 (2.76%)
         occurrences all number
    127
    148
    127
    Vomiting
         subjects affected / exposed
    2 / 258 (0.78%)
    7 / 254 (2.76%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Toothache
         subjects affected / exposed
    4 / 258 (1.55%)
    2 / 254 (0.79%)
    3 / 254 (1.18%)
         occurrences all number
    127
    148
    127
    Nausea
         subjects affected / exposed
    5 / 258 (1.94%)
    1 / 254 (0.39%)
    2 / 254 (0.79%)
         occurrences all number
    127
    148
    127
    Abdominal pain upper
         subjects affected / exposed
    2 / 258 (0.78%)
    4 / 254 (1.57%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Abdominal pain
         subjects affected / exposed
    2 / 258 (0.78%)
    2 / 254 (0.79%)
    2 / 254 (0.79%)
         occurrences all number
    127
    148
    127
    Dry mouth
         subjects affected / exposed
    1 / 258 (0.39%)
    2 / 254 (0.79%)
    3 / 254 (1.18%)
         occurrences all number
    127
    148
    127
    Abdominal discomfort
         subjects affected / exposed
    3 / 258 (1.16%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Gingival pain
         subjects affected / exposed
    2 / 258 (0.78%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Flatulence
         subjects affected / exposed
    2 / 258 (0.78%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Abdominal distension
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Abdominal rigidity
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Anal fissure
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Dental caries
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Epigastric discomfort
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Gastritis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Gastrointestinal pain
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Gingival hyperplasia
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Large intestine polyp
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Oral disorder
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Pancreatitis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Salivary hypersecretion
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Hepatobiliary disorders
    Chronic hepatitis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Hepatitis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Liver disorder
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Dermatitis contact
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Acne
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Blood blister
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Dermatitis allergic
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Eczema
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Exfoliative rash
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Hyperkeratosis
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Pruritus
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Rash
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Rosacea
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Skin reaction
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Renal and urinary disorders
    Bladder dysfunction
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Calculus urinary
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Enuresis
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Nephrolithiasis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Stag horn calculus
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Urge incontinence
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Endocrine disorders
    Hyperprolactinaemia
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 258 (1.55%)
    13 / 254 (5.12%)
    6 / 254 (2.36%)
         occurrences all number
    127
    148
    127
    Pain in extremity
         subjects affected / exposed
    1 / 258 (0.39%)
    6 / 254 (2.36%)
    4 / 254 (1.57%)
         occurrences all number
    127
    148
    127
    Arthralgia
         subjects affected / exposed
    4 / 258 (1.55%)
    2 / 254 (0.79%)
    4 / 254 (1.57%)
         occurrences all number
    127
    148
    127
    Musculoskeletal pain
         subjects affected / exposed
    4 / 258 (1.55%)
    2 / 254 (0.79%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Myalgia
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 254 (0.39%)
    2 / 254 (0.79%)
         occurrences all number
    127
    148
    127
    Neck pain
         subjects affected / exposed
    1 / 258 (0.39%)
    3 / 254 (1.18%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Muscle spasms
         subjects affected / exposed
    1 / 258 (0.39%)
    2 / 254 (0.79%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 254 (0.39%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Muscle twitching
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Costochondritis
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Flank pain
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Groin pain
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Pain in jaw
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Plantar fascial fibromatosis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Plantar fasciitis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 258 (2.71%)
    11 / 254 (4.33%)
    8 / 254 (3.15%)
         occurrences all number
    127
    148
    127
    Influenza
         subjects affected / exposed
    1 / 258 (0.39%)
    6 / 254 (2.36%)
    3 / 254 (1.18%)
         occurrences all number
    127
    148
    127
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 258 (0.78%)
    3 / 254 (1.18%)
    5 / 254 (1.97%)
         occurrences all number
    127
    148
    127
    Respiratory tract infection viral
         subjects affected / exposed
    4 / 258 (1.55%)
    2 / 254 (0.79%)
    2 / 254 (0.79%)
         occurrences all number
    127
    148
    127
    Urinary tract infection
         subjects affected / exposed
    2 / 258 (0.78%)
    4 / 254 (1.57%)
    2 / 254 (0.79%)
         occurrences all number
    127
    148
    127
    Bronchitis
         subjects affected / exposed
    3 / 258 (1.16%)
    2 / 254 (0.79%)
    2 / 254 (0.79%)
         occurrences all number
    127
    148
    127
    Tooth abscess
         subjects affected / exposed
    0 / 258 (0.00%)
    3 / 254 (1.18%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Rhinitis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    2 / 254 (0.79%)
         occurrences all number
    127
    148
    127
    Cellulitis
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Gastroenteritis viral
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Pharyngitis
         subjects affected / exposed
    1 / 258 (0.39%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Respiratory tract infection
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Tonsillitis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Abscess
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Acute sinusitis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Bacterial vaginosis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Dengue fever
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Diverticulitis
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Eye infection
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Folliculitis
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Fungal skin infection
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Furuncle
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Gastroenteritis
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Herpes zoster
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Impetigo
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Laryngitis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Mononucleosis syndrome
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Otitis externa
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Pneumonia
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Pyelonephritis chronic
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Sinusitis
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Subcutaneous abscess
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Tinea pedis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Tracheitis
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Trichomoniasis
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    2 / 258 (0.78%)
    3 / 254 (1.18%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Decreased appetite
         subjects affected / exposed
    0 / 258 (0.00%)
    2 / 254 (0.79%)
    3 / 254 (1.18%)
         occurrences all number
    127
    148
    127
    Dehydration
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Diabetes mellitus
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Hyperglycaemia
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Hyperphagia
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Hyperphosphataemia
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127
    Hypokalaemia
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
         occurrences all number
    127
    148
    127
    Overweight
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
         occurrences all number
    127
    148
    127

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2013
    Protocol Amendment 1
    08 Jul 2013
    Protocol Amendment 2
    26 Aug 2014
    Protocol Amendment 2.1
    30 Sep 2015
    Protocol Amendment 3

    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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