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    Clinical Trial Results:
    A 4-Week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexibly-dosed, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adult Subjects With Schizophrenia

    Summary
    EudraCT number
    		 2016-001555-41
    Trial protocol
    		 HU  
    Global end of trial date
    31 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Aug 2019
    First version publication date
    22 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SEP361-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02969382
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sunovion Pharmaceuticals Inc.
    Sponsor organisation address
    84 Waterford Drive, Marlborough, United States, 01752
    Public contact
    CNS Medical Director, Sunovion Pharmaceuticals Inc., 01 001-866-503-6351, CLINICALTRIALDISCLOSURE@SUNOVION.COM
    Scientific contact
    CNS Medical Director, Sunovion Pharmaceuticals Inc., 01 001-866-503-6351, CLINICALTRIALDISCLOSURE@SUNOVION.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
    31 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of flexibly dosed SEP-363856 (50 or 75 mg/day) compared with placebo in acutely psychotic adult subjects with schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS).
    Protection of trial subjects
    THE STUDY WAS CONDUCTED ACCORDING TO THE PROTOCOL, INTERNATIONAL COUNCIL FOR HARMONISATION (ICH) GOOD CLINICAL PRACTICE (GCP), ICH GUIDELINES, AND THE ETHICAL PRINCIPLES THAT HAVE THEIR ORIGIN IN THE DECLARATION OF HELSINKI.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Dec 2016
    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
    Hungary: 12
    Country: Number of subjects enrolled
    Romania: 10
    Country: Number of subjects enrolled
    Russian Federation: 98
    Country: Number of subjects enrolled
    Ukraine: 73
    Country: Number of subjects enrolled
    United States: 52
    Worldwide total number of subjects
    245
    EEA total number of subjects
    22
    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)
    245
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Informed consent were obtained before any study procedures were performed. Subjects were evaluated for eligibility and tapered off all psychotropic medications (except as noted in the protocol) in a manner consistent with labeling recommendations and conventional medical practices. Subjects remained hospitalized during the screening period.

    Pre-assignment period milestones
    Number of subjects started
    		 295 [1]
    Number of subjects completed
    		 245

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, non-fatal: 1
    Reason: Number of subjects
    		 Entry criteria not met: 39
    Reason: Number of subjects
    		 Consent withdrawn by subject: 8
    Reason: Number of subjects
    		 Other: 1
    Reason: Number of subjects
    		 Sponsor decision: 1
    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: 50 subjects never entered the trial because of screening faiure
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo capsule once daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule per day for 4 weeks

    Arm title
    		 SEP-363856
    Arm description
    		 SEP-363856 capsule (50 mg or 75 mg) once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    SEP-363856
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 50 mg capsule or one 75 mg capsule per day flexible dosing for 4 weeks

    Number of subjects in period 1
    		Placebo SEP-363856
    Started
    125
    120
    Completed
    99
    94
    Not completed
    26
    26
         Consent withdrawn by subject
    14
    9
         Adverse event, non-fatal
    8
    10
         Death
    -
    1
         Lack of efficacy
    4
    5
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo capsule once daily

    Reporting group title
    SEP-363856
    Reporting group description
    		 SEP-363856 capsule (50 mg or 75 mg) once daily

    Reporting group values
    		 Placebo SEP-363856 Total
    Number of subjects
    		 125 120 245
    Age Categorical
    Units: Subjects
        In Utero
    		 0 0 0
        Pre-term newborn - gestational age < 37 wk
    		 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)
    		 125 120 245
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 30.6 ( 6.07 ) 30.0 ( 5.76 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 46 43 89
        Male
    		 79 77 156
    Age, Customized
    Units: Subjects
        >=18 - <25
    		 29 26 55
        >=25 - <=40
    		 96 94 190
    Baseline BMI Group
    Units: Subjects
        <18.5 kg/m^2
    		 1 4 5
        >=18.5 - <25.0 kg/m^2
    		 70 59 129
        >=25.0 - <30.0 kg/m^2
    		 43 41 84
        >=30.0 kg/m^2
    		 11 16 27
    Baseline Height (cm)
    Units: cm
        arithmetic mean (standard deviation)
    		 172.7 ( 7.78 ) 173.0 ( 8.50 ) -
    Baseline Weight (kg)
    Units: kg
        arithmetic mean (standard deviation)
    		 73.74 ( 12.645 ) 75.23 ( 15.768 ) -
    Baseline Body Mass Index (kg/m^2)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 24.71 ( 3.727 ) 25.01 ( 4.238 ) -
    Baseline Waist Circumference (cm)
    Units: cm
        arithmetic mean (standard deviation)
    		 84.18 ( 12.186 ) 85.21 ( 14.191 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo capsule once daily

    Reporting group title
    SEP-363856
    Reporting group description
    		 SEP-363856 capsule (50 mg or 75 mg) once daily

    Primary: Change from Baseline in PANSS total score at Week 4

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    End point title
    		 Change from Baseline in PANSS total score at Week 4
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Placebo SEP-363856
    Number of subjects analysed
    125
    120
    Units: Units on a scale
        least squares mean (standard error)
    -9.7 ( 1.61 )
    -17.2 ( 1.66 )
    Statistical analysis title
    		 Mixed Model for Repeated Measures (MMRM)
    Comparison groups
    Placebo v SEP-363856
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -7.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.9
         upper limit
    		 -3
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.23

    Secondary: Change from Baseline in CGI-S score at Week 4

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    End point title
    		 Change from Baseline in CGI-S score at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Placebo SEP-363856
    Number of subjects analysed
    125
    120
    Units: Units on a scale
        least squares mean (standard error)
    -0.5 ( 0.09 )
    -1.0 ( 0.09 )
    Statistical analysis title
    		 Mixed Model for Repeated Measures (MMRM)
    Comparison groups
    Placebo v SEP-363856
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12

    Secondary: Change from Baseline in PANSS Positive Subscale score at Week 4

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    End point title
    		 Change from Baseline in PANSS Positive Subscale score at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Placebo SEP-363856
    Number of subjects analysed
    125
    120
    Units: Units on a scale
        least squares mean (standard error)
    -3.9 ( 0.51 )
    -5.5 ( 0.53 )
    Statistical analysis title
    		 Mixed Model for Repeated Measures (MMRM)
    Comparison groups
    Placebo v SEP-363856
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.019
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.71

    Secondary: Change from Baseline in PANSS Negative Subscale score at Week 4

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    End point title
    		 Change from Baseline in PANSS Negative Subscale score at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Placebo SEP-363856
    Number of subjects analysed
    125
    120
    Units: Units on a scale
        least squares mean (standard error)
    -1.6 ( 0.41 )
    -3.1 ( 0.42 )
    Statistical analysis title
    		 Mixed Model for Repeated Measures (MMRM)
    Comparison groups
    Placebo v SEP-363856
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 -0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.55

    Secondary: Change from Baseline in PANSS General Psychopathology Subscale score at Week 4

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    End point title
    		 Change from Baseline in PANSS General Psychopathology Subscale score at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Placebo SEP-363856
    Number of subjects analysed
    125
    120
    Units: Units on a scale
        least squares mean (standard error)
    -4.7 ( 0.84 )
    -9.0 ( 0.87 )
    Statistical analysis title
    		 Mixed Model for Repeated Measures (MMRM)
    Comparison groups
    Placebo v SEP-363856
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.6
         upper limit
    		 -2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.15

    Secondary: Change from Baseline in BNSS total score at Week 4

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    End point title
    		 Change from Baseline in BNSS total score at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Placebo SEP-363856
    Number of subjects analysed
    119
    113
    Units: Units on a scale
        least squares mean (standard error)
    -2.7 ( 0.91 )
    -7.1 ( 0.95 )
    Statistical analysis title
    		 Mixed Model for Repeated Measures (MMRM)
    Comparison groups
    Placebo v SEP-363856
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.8
         upper limit
    		 -1.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.26

    Secondary: Change from Baseline in MADRS total score at Week 4

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    End point title
    		 Change from Baseline in MADRS total score at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Placebo SEP-363856
    Number of subjects analysed
    125
    120
    Units: Units on a scale
        least squares mean (standard error)
    -1.6 ( 0.57 )
    -3.3 ( 0.59 )
    Statistical analysis title
    		 Mixed Model for Repeated Measures (MMRM)
    Comparison groups
    Placebo v SEP-363856
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.75

    Secondary: PANSS response at Week 4, defined as a 20% or greater improvement from Baseline in PANSS total score

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    End point title
    		 PANSS response at Week 4, defined as a 20% or greater improvement from Baseline in PANSS total score
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Placebo SEP-363856
    Number of subjects analysed
    100
    96
    Units: Subjects
    44
    62
    Statistical analysis title
    		 Logistic Regression
    Comparison groups
    Placebo v SEP-363856
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.645
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.422
         upper limit
    		 4.921

    Secondary: Incidence of overall adverse events

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    End point title
    		 Incidence of overall adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    From first dose of study drug to last study visit
    End point values
    		 Placebo SEP-363856
    Number of subjects analysed
    125
    120
    Units: Subjects
    63
    55
    No statistical analyses for this end point

    Secondary: Incidence of serious adverse events

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    End point title
    		 Incidence of serious adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    From first dose of study drug to last study visit
    End point values
    		 Placebo SEP-363856
    Number of subjects analysed
    125
    120
    Units: Subjects
    3
    2
    No statistical analyses for this end point

    Secondary: Incidence of adverse events leading to discontinuation of study drug

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    End point title
    		 Incidence of adverse events leading to discontinuation of study drug
    End point description
    End point type
    Secondary
    End point timeframe
    From first dose of study drug to last study visit
    End point values
    		 Placebo SEP-363856
    Number of subjects analysed
    125
    120
    Units: Subjects
    8
    10
    No statistical analyses for this end point

    Secondary: Incidence of adverse events leading to discontinuation from study

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    End point title
    		 Incidence of adverse events leading to discontinuation from study
    End point description
    End point type
    Secondary
    End point timeframe
    From first dose of study drug to last study visit
    End point values
    		 Placebo SEP-363856
    Number of subjects analysed
    125
    120
    Units: Subjects
    8
    11
    No statistical analyses for this end point

    Secondary: Frequency of subjects with suicidal ideation using the C-SSRS

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    End point title
    		 Frequency of subjects with suicidal ideation using the C-SSRS
    End point description
    End point type
    Secondary
    End point timeframe
    Overall post-Baseline double-blind treatment period
    End point values
    		 Placebo SEP-363856
    Number of subjects analysed
    125
    120
    Units: Subjects
    2
    0
    Statistical analysis title
    		 Fisher's Exact Test
    Comparison groups
    Placebo v SEP-363856
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.498
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Frequency of subjects with suicidal behavior using the C-SSRS

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    End point title
    		 Frequency of subjects with suicidal behavior using the C-SSRS
    End point description
    End point type
    Secondary
    End point timeframe
    Overall post-Baseline double-blind treatment period
    End point values
    		 Placebo SEP-363856
    Number of subjects analysed
    125
    120
    Units: Subjects
    1
    0
    Statistical analysis title
    		 Fisher's Exact Test
    Comparison groups
    Placebo v SEP-363856
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.999
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Frequency of subjects with suicidality using the C-SSRS

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    End point title
    		 Frequency of subjects with suicidality using the C-SSRS
    End point description
    End point type
    Secondary
    End point timeframe
    Overall post-Baseline double-blind treatment period
    End point values
    		 Placebo SEP-363856
    Number of subjects analysed
    125
    120
    Units: Subjects
    2
    0
    Statistical analysis title
    		 Fisher's Exact Test
    Comparison groups
    Placebo v SEP-363856
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.498
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    5 weeks (from first dose of study drug to last study visit)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo capsule once daily

    Reporting group title
    SEP-363856
    Reporting group description
    		 SEP-363856 capsule (50 mg or 75 mg) once daily

    Serious adverse events
    		 Placebo SEP-363856
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 125 (2.40%)
    2 / 120 (1.67%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Cardiac disorders
    Cardiovascular insufficiency
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    3 / 125 (2.40%)
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 120 (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: 5%
    Non-serious adverse events
    		 Placebo SEP-363856
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 125 (37.60%)
    35 / 120 (29.17%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    6 / 125 (4.80%)
    8 / 120 (6.67%)
         occurrences all number
    6
    8
    Headache
         subjects affected / exposed
    15 / 125 (12.00%)
    11 / 120 (9.17%)
         occurrences all number
    18
    15
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 125 (3.20%)
    6 / 120 (5.00%)
         occurrences all number
    4
    7
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    6 / 125 (4.80%)
    6 / 120 (5.00%)
         occurrences all number
    6
    6
    Anxiety
         subjects affected / exposed
    9 / 125 (7.20%)
    2 / 120 (1.67%)
         occurrences all number
    12
    2
    Insomnia
         subjects affected / exposed
    13 / 125 (10.40%)
    4 / 120 (3.33%)
         occurrences all number
    20
    5
    Schizophrenia
         subjects affected / exposed
    7 / 125 (5.60%)
    7 / 120 (5.83%)
         occurrences all number
    8
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Mar 2017
    The following major changes/clarifications, including Nonsubstantial Amendment 1 (08 Sep 2016) and Nonsubstantial Amendment 2 (07 Oct 2016) were included in the Version 3.00 protocol: • Clarified that the DEQ was designed to assess subjective effects only. • Clarified that subjects would remain hospitalized for the duration of the screening/washout period. • Clarified inclusion criteria for acute exacerbation of psychotic symptoms and prior hospitalizations. • Clarified exclusion criterion for antipsychotic medications less than 2 weeks in duration and removed exclusion criterion for subjects with past episodes of significant extrapyramidal symptoms (EPS). • Added PANSS randomization criteria. • If a subject was issued a day pass, an unscheduled urine drug screen upon returning to the site was added. • Added unscheduled collection of SAS, BARS, and AIMS scales if a subject developed EPS requiring treatment. • Clarified prior medications washout for clozapine; added zopiclone as a permitted medication at the discretion of the Investigator; removed codeine, hydrocodone, and methadone as prohibited medications; and clarified that all concomitant antipsychotic medications were prohibited. • Clarified that subjects were allowed 7 days to stabilize in hospital if they did not meet discharge criteria at Visit 7 or early termination. • Updated the order of assessments so that C-SSRS is performed before the CGI-S and that visit day study drug administration occurred after completion of scale assessments.

    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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