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    Clinical Trial Results:
    A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence

    Summary
    EudraCT number
    		 2021-000240-22
    Trial protocol
    		 BE   DE  
    Global end of trial date
    14 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2024
    First version publication date
    28 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M21-310
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04994535
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.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
    14 Jun 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study was to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence. Study doctors randomized subjects into 1 of the 2 groups, called treatment arms. There was a 1 in 2 chance that a subject was assigned to placebo. Approximately 400 subjects were to be enrolled in the study across approximately 35 sites in USA, Belgium, Canada, Germany and the UK. Subjects received a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study. Subjects attended regular monthly visits during the study at the study site.
    Protection of trial subjects
    Subjects read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Aug 2021
    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
    Belgium: 16
    Country: Number of subjects enrolled
    Canada: 59
    Country: Number of subjects enrolled
    Germany: 76
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    United States: 265
    Worldwide total number of subjects
    426
    EEA total number of subjects
    92
    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)
    417
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 426 subjects were enrolled and randomized into the study (ITT Population); 209 to BOTOX and 217 to placebo. A total of 208 subjects were treated with BOTOX and 216 subjects were treated with placebo (Safety Analysis Set). A total of 381 subjects were included in the modified ITT (mITT) Population; 186 to BOTOX and 195 to placebo.

    Pre-assignment
    Screening details
    		 The mITT Population (N=381) included all randomized subjects with a baseline summary score ≥ 19 on the ANLFQ: Impacts questionnaire and was used for the reported efficacy analyses. The Safety Analysis Set (N=424) included all subjects treated with at least 1 dose of study drug and was used for all safety analyses.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo was injected into the platysma muscle on Day 1
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Saline injection
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    Placebo was injected into the platysma muscle on Day 1

    Arm title
    		 BOTOX
    Arm description
    		 BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
    Arm type
    		 Experimental

    Investigational medicinal product name
    OnabotulinumtoxinA
    Investigational medicinal product code
    Other name
    BOTOX
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    BOTOX was injected into the platysma muscle on Day 1

    Number of subjects in period 1
    		Placebo BOTOX
    Started
    217
    209
    Completed
    199
    194
    Not completed
    18
    15
         Other
    1
    1
         Lost to follow-up
    7
    7
         Withdrawal by subject
    10
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was injected into the platysma muscle on Day 1

    Reporting group title
    BOTOX
    Reporting group description
    		 BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1

    Reporting group values
    		 Placebo BOTOX Total
    Number of subjects
    		 217 209 426
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 210 207 417
        From 65-84 years
    		 7 2 9
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.9 ( 10.18 ) 48.0 ( 9.57 ) -
    Gender categorical
    Units: Subjects
        Female
    		 206 198 404
        Male
    		 11 11 22
    Race
    Units: Subjects
        White
    		 202 191 393
        Black or African American
    		 5 2 7
        Asian
    		 8 11 19
        More than one race
    		 2 4 6
        American Indian or Alaska Native
    		 0 1 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 35 30 65
        Not Hispanic or Latino
    		 182 179 361

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was injected into the platysma muscle on Day 1

    Reporting group title
    BOTOX
    Reporting group description
    		 BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1

    Primary: Number of Participants with Adverse Events

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    End point title
    		 Number of Participants with Adverse Events [1]
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
    End point type
    Primary
    End point timeframe
    Enrollment to Day 120
    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: Descriptive data are summarized for this end point per protocol.
    End point values
    		 Placebo BOTOX
    Number of subjects analysed
    216
    208
    Units: subjects
    43
    34
    No statistical analyses for this end point

    Primary: Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self-Assessment Using P-APPS at Maximum Contraction at Day 14

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    End point title
    		 Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self-Assessment Using P-APPS at Maximum Contraction at Day 14
    End point description
    The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for subjects to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
    End point type
    Primary
    End point timeframe
    Day 14
    End point values
    		 Placebo BOTOX
    Number of subjects analysed
    195
    186
    Units: Percentage of subjects
        number (confidence interval 95%)
    3.9 (1.1 to 6.7)
    40.8 (33.5 to 48.1)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v BOTOX
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference (%)
    Point estimate
    36.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 29.1
         upper limit
    		 44.7
    Notes
    [2] - P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.

    Primary: Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14

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    End point title
    		 Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14
    End point description
    The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
    End point type
    Primary
    End point timeframe
    Day 14
    End point values
    		 Placebo BOTOX
    Number of subjects analysed
    195
    186
    Units: Percentage of subjects
        number (confidence interval 95%)
    2.2 (0 to 4.3)
    41.0 (33.8 to 48.3)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v BOTOX
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference (%)
    Point estimate
    38.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 31.3
         upper limit
    		 46.4
    Notes
    [3] - P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.

    Secondary: Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90

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    End point title
    		 Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90
    End point description
    The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher scores indicating greater negative impact from the appearance of the neck and lower face.
    End point type
    Secondary
    End point timeframe
    Day 30, Day 60, Day 90
    End point values
    		 Placebo BOTOX
    Number of subjects analysed
    195
    186
    Units: Score on a Scale
    least squares mean (standard error)
        Day 30
    -3.9 ( 0.54 )
    -8.8 ( 0.55 )
        Day 60
    -3.5 ( 0.56 )
    -8.2 ( 0.56 )
        Day 90
    -3.5 ( 0.50 )
    -7.4 ( 0.50 )
    Statistical analysis title
    		 Statistical Analysis 1 [30 Days]
    Comparison groups
    Placebo v BOTOX
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Difference (standard error)
    Point estimate
    -4.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6
         upper limit
    		 -3.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.58
    Notes
    [4] - P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.
    Statistical analysis title
    		 Statistical Analysis 2 [60 Days]
    Comparison groups
    Placebo v BOTOX
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [5]
    Method
    		 ANCOVA
    Parameter type
    		 Difference (standard error)
    Point estimate
    -4.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.9
         upper limit
    		 -3.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.59
    Notes
    [5] - P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.
    Statistical analysis title
    		 Statistical Analysis 3 [90 Days]
    Comparison groups
    Placebo v BOTOX
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Difference (standard error)
    Point estimate
    -3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 -2.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.54

    Secondary: Percentage of Participants Who Achieved a Rating of Minimal or Mild According to Participant's Self-Assessment Using P-APPS at Maximum Contraction at Days 14

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    End point title
    		 Percentage of Participants Who Achieved a Rating of Minimal or Mild According to Participant's Self-Assessment Using P-APPS at Maximum Contraction at Days 14
    End point description
    The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Placebo BOTOX
    Number of subjects analysed
    195
    186
    Units: Percentage of Subjects
        number (confidence interval 95%)
    5.2 (1.9 to 8.4)
    48.1 (40.7 to 55.5)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v BOTOX
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference (%)
    Point estimate
    42.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 34.8
         upper limit
    		 51
    Notes
    [6] - P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.

    Secondary: Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 2 (Jawline) at Day 14

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    End point title
    		 Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 2 (Jawline) at Day 14
    End point description
    The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Placebo BOTOX
    Number of subjects analysed
    195
    186
    Units: Percentage of Subjects
        number (confidence interval 95%)
    20.6 (14.7 to 26.4)
    49.4 (42.1 to 56.7)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v BOTOX
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference (%)
    Point estimate
    28.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.4
         upper limit
    		 38.2
    Notes
    [7] - P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.

    Secondary: Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14

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    End point title
    		 Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14
    End point description
    The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Placebo BOTOX
    Number of subjects analysed
    195
    186
    Units: Percentage of Subjects
        number (confidence interval 95%)
    11.9 (7.2 to 16.6)
    47.8 (40.5 to 55.1)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v BOTOX
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference (%)
    Point estimate
    35.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27.2
         upper limit
    		 44.6
    Notes
    [8] - P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.

    Secondary: Change From Baseline on the ANLFQ: Impacts Summary Score at Day 14

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    End point title
    		 Change From Baseline on the ANLFQ: Impacts Summary Score at Day 14
    End point description
    The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher scores indicating greater negative impact from the appearance of the neck and lower face.
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Placebo BOTOX
    Number of subjects analysed
    195
    186
    Units: Score on a Scale
        least squares mean (standard error)
    -3.0 ( 0.50 )
    -7.7 ( 0.51 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v BOTOX
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [9]
    Method
    		 ANCOVA
    Parameter type
    		 Difference (standard error)
    Point estimate
    -4.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.8
         upper limit
    		 -3.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.54
    Notes
    [9] - P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.

    Secondary: Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14

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    End point title
    		 Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14
    End point description
    The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied).
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    		 Placebo BOTOX
    Number of subjects analysed
    195
    186
    Units: Percentage of subjects
        number (confidence interval 95%)
    11.8 (7.0 to 16.6)
    61.2 (54.0 to 68.4)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v BOTOX
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference (%)
    Point estimate
    49.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 40.8
         upper limit
    		 58.1
    Notes
    [10] - P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    BOTOX
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo BOTOX
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 216 (0.46%)
    0 / 208 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Reproductive system and breast disorders
    ADNEXA UTERI CYST
         subjects affected / exposed
    1 / 216 (0.46%)
    0 / 208 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo BOTOX
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 216 (2.78%)
    7 / 208 (3.37%)
    Infections and infestations
    COVID-19
         subjects affected / exposed
    6 / 216 (2.78%)
    7 / 208 (3.37%)
         occurrences all number
    6
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Oct 2021
    Protocol Version 2.0 (Amendment 1) In addition to administrative and clerical edits made to align with current protocol standards/templates, the following edits were included: • Updates to timing of C-APPS and P-APPS evaluations • A gated enrollment strategy was added • COVID-19-related acceptable protocol modifications were deleted for PROs
    02 Aug 2022
    Protocol Version 3.0 (Amendment 2) In addition to the correction of minor clerical errors for consistency throughout the protocol, the following changes were included: • Updated Sponsor contact information • Updated supporting information and eligibility criteria related to COVID-19 • Clarified that prohibited medication/treatment listed are prohibitive due to the potential confounding impact to efficacy assessment and not due to any potential safety risk to the subject • Clarified the investigational medicinal product and updated units • Added statement that partner pregnancy information will not be collected • Updated the number of imputation datasets • Updated definition of end-of-study
    22 Nov 2022
    Protocol Version 4.0 (Amendment 3) In addition to the correction of minor clerical errors for consistency throughout the protocol, the following changes were included: • Updates and clarifications to endpoints for the US • Reordered endpoints • Updated responder definitions for additional analyses of C-APPS/P-APPS • Updated eligibility criterion 26 • Updates and clarifications to statistical analysis procedures • Updates to safety data overview • Updated confidentiality section per AbbVie standard for studies conducted in EMA

    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
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