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    Clinical Trial Results:
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF SAGE-217 IN THE TREATMENT OF ADULTS WITH SEVERE POSTPARTUM DEPRESSION

    Summary
    EudraCT number
    		 2020-001424-34
    Trial protocol
    		 GB  
    Global end of trial date
    12 Apr 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2023
    First version publication date
    27 Apr 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    217-PPD-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04442503
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sage Therapeutics, Inc.
    Sponsor organisation address
    215 First Street, Cambridge, United States, 02142
    Public contact
    Handan Gunduz-Bruce, MD, MBA, Sage Therapeutics, Inc., +1 617949 2883, handan.gunduz-bruce@sagerx.com
    Scientific contact
    Handan Gunduz-Bruce, MD, MBA, Sage Therapeutics, Inc., +1 617949 2883, handan.gunduz-bruce@sagerx.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 Apr 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Apr 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine if treatment with SAGE-217 reduces depressive symptoms in adults with severe postpartum depression (PPD) compared to placebo.
    Protection of trial subjects
    This study was conducted in accordance with applicable International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines, as well as local regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jun 2020
    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
    Spain: 3
    Country: Number of subjects enrolled
    United States: 191
    Country: Number of subjects enrolled
    United Kingdom: 2
    Worldwide total number of subjects
    196
    EEA total number of subjects
    3
    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)
    196
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects took part in study at 92 investigational sites in Spain, United Kingdom and United States from 8 June 2020 to 12 April 2022.

    Pre-assignment
    Screening details
    		 The study enrolled 200 subjects and of which 196 subjects received treatment.

    Pre-assignment period milestones
    Number of subjects started
    		 200 [1]
    Number of subjects completed
    		 196

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Randomised but not treated: 4
    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: 200 subjects started the trial but only 196 received the study treatment.
    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
    		 Investigator, Monitor, Subject, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received SAGE-217 matched-placebo capsules, orally, once daily for 14 days.
    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
    SAGE-217 matched-placebo oral capsules.

    Arm title
    		 Sage 217 50 mg
    Arm description
    		 Subjects received SAGE-217, 50 mg, capsules, orally, once daily for 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SAGE-217
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    SAGE-217 oral capsules.

    Number of subjects in period 1
    		Placebo Sage 217 50 mg
    Started
    98
    98
    Completed
    86
    84
    Not completed
    12
    14
         Physician decision
    -
    2
         Adverse Event
    1
    1
         Withdrawal by Subject
    3
    4
         Lost to follow-up
    8
    6
         Reason not Specified
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received SAGE-217 matched-placebo capsules, orally, once daily for 14 days.

    Reporting group title
    Sage 217 50 mg
    Reporting group description
    		 Subjects received SAGE-217, 50 mg, capsules, orally, once daily for 14 days.

    Reporting group values
    		 Placebo Sage 217 50 mg Total
    Number of subjects
    		 98 98 196
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 98 98 196
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 31.0 ± 5.95 30.0 ± 5.90 -
    Gender categorical
    Units: Subjects
        Female
    		 98 98 196
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received SAGE-217 matched-placebo capsules, orally, once daily for 14 days.

    Reporting group title
    Sage 217 50 mg
    Reporting group description
    		 Subjects received SAGE-217, 50 mg, capsules, orally, once daily for 14 days.

    Primary: Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15

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    End point title
    		 Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15
    End point description
    17-item HAM-D scale assesses severity of depression related to: depressed mood (sadness,hopeless,helpless,worthless),feelings of guilt,suicide,insomnia (early,middle,late), work and activities (slowness of thought and speech;impaired ability to concentrate;decreased motor activity), retardation,agitation,anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis,loss of weight, and insight. Individual items are scored on 3-point (0 to 2) or 5-point scale (0 to 4), with 0=none/absent and 4=most severe. Total score is sum of 17 items, from 0 to 52; higher score=more depression. Negative CFB=improvement. MMRM was used for analysis. Full Analysis Set (FAS)=all randomised subjects who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. n=subjects with data available for analyses.
    End point type
    Primary
    End point timeframe
    Baseline and Day 15
    End point values
    		 Placebo Sage 217 50 mg
    Number of subjects analysed
    97
    98
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 97, 98)
    28.8 ± 2.34
    28.6 ± 2.49
        Change from Baseline at Day 15 (n=90, 93)
    -11.4 ± 8.50
    -15.6 ± 7.62
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Change from Baseline at Day 15
    Comparison groups
    Sage 217 50 mg v Placebo
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0007
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.3
         upper limit
    		 -1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.16

    Secondary: Change From Baseline in the 17-item HAM-D Total Score

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    End point title
    		 Change From Baseline in the 17-item HAM-D Total Score
    End point description
    17-item HAM-D scale assesses severity of depression related to: depressed mood (sadness,hopeless,helpless,worthless),feelings of guilt,suicide,insomnia (early,middle,late), work and activities (slowness of thought and speech;impaired ability to concentrate;decreased motor activity), retardation,agitation,anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis,loss of weight, and insight. Individual items are scored on 3-point (0 to 2) or 5-point scale (0 to 4), with 0=none/absent and 4=most severe. Total score is sum of 17 items, from 0 to 52; higher score=more depression. Negative CFB=improvement. MMRM was used for analysis. Full Analysis Set (FAS)=all randomised subjects who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. n=subjects with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 3, 28 and 45
    End point values
    		 Placebo Sage 217 50 mg
    Number of subjects analysed
    97
    98
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n=97, 98)
    28.8 ± 2.34
    28.6 ± 2.49
        Change from Baseline at Day 3 (n=96, 98)
    -6.3 ± 6.78
    -9.5 ± 7.40
        Change from Baseline at Day 28 (n=85, 77)
    -13.5 ± 8.77
    -16.3 ± 8.34
        Change from Baseline at Day 45 (n=85, 84)
    -14.8 ± 9.09
    -17.7 ± 8.40
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Change from Baseline at Day 3
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0008
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.4
         upper limit
    		 -1.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.999
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Change from Baseline at Day 45
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0067
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6
         upper limit
    		 -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.277
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Change from Baseline at Day 28
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0203
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.4
         upper limit
    		 -0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.244

    Secondary: Change From Baseline in Clinical Global Impressions - Severity Scale (CGI-S) Score

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    End point title
    		 Change From Baseline in Clinical Global Impressions - Severity Scale (CGI-S) Score
    End point description
    CGI-S is a 7-point Likert scale to rate the severity of subject’s illness at time of assessment, relative to the clinician’s past experience with subjects who had same diagnosis. Subject was assessed on severity of mental illness at time of rating as 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7= extremely ill subjects. Lower score indicates better outcome. A negative change from baseline indicates improvement. MMRM was used for analysis. FAS=all randomised subjects who received any amount of IP and had a valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. n=Number analysed is the number of subjects with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 15
    End point values
    		 Placebo Sage 217 50 mg
    Number of subjects analysed
    97
    98
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n=97, 98)
    4.9 ± 0.58
    5.0 ± 0.66
        Change from Baseline at Day 15 (n=90, 93)
    -1.6 ± 1.38
    -2.2 ± 1.51
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Change from Baseline at Day 15
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0052
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.196

    Secondary: Percentage of Subjects With HAM-D Response

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    End point title
    		 Percentage of Subjects With HAM-D Response
    End point description
    17-item HAM-D scale=severity of depression related to:depressed mood,feelings of guilt, suicide, insomnia, work and activities (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), retardation, agitation, anxiety(psychic and somatic),somatic symptoms(gastrointestinal and general),genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on 3-point (0to2) or 5-point scale (0to4), with 0=none/absent and 4=most severe. Total score=sum of 17 items, ranges from 0to52; higher score=more depression. Negative CFB=improvement. HAM-D response= ≥50% reduction in HAM-D total score from baseline. FAS=all randomised subjects who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. n=subjects with data available for analyses. Percentages are rounded off to nearest whole number.
    End point type
    Secondary
    End point timeframe
    Days 15 and 45
    End point values
    		 Placebo Sage 217 50 mg
    Number of subjects analysed
    97
    98
    Units: percentage of participants
    number (not applicable)
        Day 15 (n= 90, 93)
    38.9
    57.0
        Day 45 (n= 85, 84)
    54.1
    61.9
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Day 45
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1661 [1]
    Method
    		 GEE Model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.534
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.837
         upper limit
    		 2.812
    Notes
    [1] - P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Day 15
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0209 [2]
    Method
    		 GEE Model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.112
         upper limit
    		 3.67
    Notes
    [2] - P-value are from a generalized estimating equation (GEE) for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.

    Secondary: Percentage of Subjects With HAM-D Remission

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    End point title
    		 Percentage of Subjects With HAM-D Remission
    End point description
    HAM-D remission=having a HAM-D total score of <=7.17-item HAM-D scale=severity of depression related to the following symptoms: depressed mood (sadness,hopeless,helpless,worthless),feelings of guilt,suicide,insomnia (early,middle,late), work and activities(slowness of thought and speech;impaired ability to concentrate;decreased motor activity),retardation,agitation,anxiety (psychic and somatic),somatic symptoms (gastrointestinal and general),genital symptoms, hypochondriasis,loss of weight,and insight. Individual items are scored on 3-point (0 to 2) or 5-point scale (0 to 4), with 0=none/absent and 4=most severe. Total score=sum of 17 items, ranges from 0 to 52; higher score=more depression. Negative CFB=improvement. FAS=all randomised subjects who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I.n=subjects available for analysis.
    End point type
    Secondary
    End point timeframe
    Days 15 and 45
    End point values
    		 Placebo Sage 217 50 mg
    Number of subjects analysed
    97
    98
    Units: percentage of participants
    number (not applicable)
        Day 15 (n= 90, 93)
    16.7
    26.9
        Day 45 (n= 85, 84)
    29.4
    44.0
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Day 45
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0226 [3]
    Method
    		 GEE Model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.083
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.108
         upper limit
    		 3.915
    Notes
    [3] - P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Day 15
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.111 [4]
    Method
    		 GEE Model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.781
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.876
         upper limit
    		 3.621
    Notes
    [4] - P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.

    Secondary: Percentage of Subjects With Clinical Global Impression - Improvement (CGI-I) Response

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    End point title
    		 Percentage of Subjects With Clinical Global Impression - Improvement (CGI-I) Response
    End point description
    CGI-I response was defined as having a CGI-I score of “very much improved” or “much improved.” CGI-I employs a 7-point Likert scale to measure the overall improvement in the subject's condition posttreatment. The investigator rated the subject's total improvement whether or not it is due entirely to drug treatment. Response choices include 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The CGI-I was only rated at posttreatment assessments. FAS included all randomized subjects who received any amount of IP and had a valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I.Hamilton Rating Scale for Depression (HAM-D) total score. N=number analysed is the number of subjects available for analyses. n=Number analysed is the number of subjects with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Day 15
    End point values
    		 Placebo Sage 217 50 mg
    Number of subjects analysed
    90
    93
    Units: percentage of subjects
        number (not applicable)
    46.7
    66.7
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Day 15
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0089 [5]
    Method
    		 GEE
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.223
         upper limit
    		 4.072
    Notes
    [5] - P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.

    Secondary: Change From Baseline in Hamilton Rating Scale for Anxiety (HAM-A) Total Score

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    End point title
    		 Change From Baseline in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
    End point description
    14-item HAM-A was used to rate the severity of symptoms of anxiety. Each 14-items were defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The HAM-A total score was calculated as the sum of the 14 individual item scores. The scoring for HAM-A is calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56 where <17 indicated mild severity, 18 to 24, mild to moderate severity, and 25 to 30, moderate to severe severity. A negative change from baseline in HAM-A total score indicated improvement. FAS included all randomized subjects who received any amount of IP and had a valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. n= subjects with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 15
    End point values
    		 Placebo Sage 217 50 mg
    Number of subjects analysed
    97
    98
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n=97, 98)
    24.7 ± 5.96
    24.4 ± 6.01
        Change from Baseline at Day 15 (n= 90, 92)
    -10.4 ± 7.15
    -13.0 ± 8.19
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Change from Baseline at Day 15
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0235 [6]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.98
    Notes
    [6] - P-value is from a MMRM; the model includes treatment (SAGE-217 or placebo), baseline HAM-A total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as explanatory variables.

    Secondary: Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score

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    End point title
    		 Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score
    End point description
    MADRS total score was calculated as sum of the 10 individual item scores. MADRS is a 10-item diagnostic questionnaire used to measure severity of depressive episodes in subjects with mood disorders. It includes questions on following: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item is rated on 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). Total score ranges 0 to 60 with higher score=more depression. A negative CFB in MADRS total score indicated improvement. FAS included all randomized subjects who received any amount of IP and had a valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I.N=subjects available for analysis. n=subjects with data available for analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 15
    End point values
    		 Placebo Sage 217 50 mg
    Number of subjects analysed
    97
    98
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 96, 98)
    35.0 ± 4.81
    35.5 ± 5.37
        Change from Baseline at Day 15 (n= 89, 92)
    -14.1 ± 11.78
    -19.9 ± 12.00
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Change from Baseline at Day 15
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0034
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.4
         upper limit
    		 -1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.706

    Secondary: Change From Baseline in HAM-D Subscale

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    End point title
    		 Change From Baseline in HAM-D Subscale
    End point description
    The 17-item HAM-D is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. HAM-D subscale scores will be calculated as the sum of the items comprising each subscale. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. FAS population. n=Number analysed is the number of subjects with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 15
    End point values
    		 Placebo Sage 217 50 mg
    Number of subjects analysed
    97
    98
    Units: score on a scale
    arithmetic mean (standard deviation)
        Core Subscale Baseline (n=97,98)
    47.6 ± 6.96
    49.2 ± 6.79
        CFB in Core Subscale at Day 15 (n=90,93)
    -20.4 ± 18.49
    -27.7 ± 16.36
        Anxiety Subscale Baseline (n=97,98)
    52.6 ± 9.23
    51.2 ± 8.79
        CFB in Anxiety Subscale at Day 15 (n=90,93)
    -20.4 ± 17.28
    -26.0 ± 15.66
        Bech-6-Subscale Baseline (n=97,98)
    62.9 ± 6.14
    63.7 ± 5.64
        CFB in Bech-6 Subscale at Day 15 (n=90,93)
    -24.6 ± 21.37
    -34.3 ± 19.61
        Meier Subscale Baseline (n=97,98)
    56.3 ± 5.94
    56.9 ± 6.11
        CFB in in Meier Subscale at Day 15 (n=90,93)
    -22.5 ± 18.99
    -30.7 ± 17.23
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Change from Baseline in Meier Subscale at Day 15
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0041
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -7.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.7
         upper limit
    		 2.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.609
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Change from Baseline (CFB) in Core Subscale at Day 15
    Comparison groups
    Sage 217 50 mg v Placebo
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0151
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -5.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.6
         upper limit
    		 -1.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.4
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    CFB in Anxiety Subscale at Day 15
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0123
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -5.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.2
         upper limit
    		 -1.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.27
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    CFB in Bech-6 Subscale at Day 15
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -8.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.5
         upper limit
    		 -2.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.96

    Secondary: Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the Edinburgh Postnatal Depression Scale (EPDS) Total Score

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    End point title
    		 Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the Edinburgh Postnatal Depression Scale (EPDS) Total Score
    End point description
    The EPDS is a self-rated depressive symptom severity scale specific to the perinatal period which consists of 10 individual items. Each item is rated on a 4-point scale ranging from 0 to 3 points, where 0=minimal depression and 3=severe depression. The EPDS total score is calculated as the sum of the 10 individual item scores, ranging from 0 points to 30 points with a higher score indicating more depression. A negative change indicates improvement. FAS included all randomised subjects who received any amount of IP and had a valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. n=Number analysed is the number of subjects with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 3, 8,15, 21, 28 and 45
    End point values
    		 Placebo Sage 217 50 mg
    Number of subjects analysed
    97
    98
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 97, 98)
    20.0 ± 4.15
    21.1 ± 3.68
        Change from Baseline at Day 3 (n= 94, 97)
    -2.2 ± 4.50
    -4.2 ± 5.34
        Change from Baseline at Day 8 (n= 95, 93)
    -6.0 ± 6.20
    -8.9 ± 7.01
        Change from Baseline at Day 15 (n= 89, 91)
    -8.0 ± 6.41
    -10.8 ± 7.18
        Change from Baseline at Day 21 (n= 81, 84)
    -8.7 ± 6.65
    -10.9 ± 6.72
        Change from Baseline at Day 28 (n= 85, 76)
    -9.4 ± 6.48
    -11.6 ± 7.83
        Change from Baseline at Day 45 (n= 85, 84)
    -9.7 ± 7.40
    -12.3 ± 7.87
    No statistical analyses for this end point

    Secondary: Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the 9-item Patient Health Questionnaire (PHQ-9) Score

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    End point title
    		 Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the 9-item Patient Health Questionnaire (PHQ-9) Score
    End point description
    PHQ-9 is a self-rated depressive symptom severity scale to monitor severity over time for newly diagnosed subjects or in current treatment for depression. Scoring was based on responses to 9 specific questions as follows: 0=not at all; 1=several days; 2 = more than half the days; and 3=nearly every day. Score were calculated as the sum of the 9 individual item scores. PHQ-9 total score was categorised as: 1 to 4=minimal depression, 5 to 9=mild depression, 10 to 14 =moderate depression, 15 to 19=moderately severe depression; and 20 to 27 =severe depression. PHQ-9 total score ranges from 1 to 27 with a higher score=more depression. Negative CFB indicates reduced depression. MMRM was used for analysis. FAS=all randomised subjects who received any amount of IP and had a valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. n=subjects with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 3, 8,15, 21, 28 and 45
    End point values
    		 Placebo Sage 217 50 mg
    Number of subjects analysed
    97
    98
    Units: score on a scale
    least squares mean (standard error)
        Change from Baseline at Day 3(n=94,97)
    -2.3 ± 0.462
    -2.0 ± 0.456
        Change from Baseline at Day 8(n=95,93)
    -5.9 ± 0.617
    -7.7 ± 0.620
        Change from Baseline at Day 15(n=90,91)
    -8.6 ± 0.652
    -10.5 ± 0.651
        Change from Baseline at Day 21(n=81,84)
    -9.0 ± 0.655
    -10.6 ± 0.651
        Change from Baseline at Day 28(n=85,77)
    -9.2 ± 0.692
    -10.5 ± 0.703
        Change from Baseline at Day 45(n=85,84)
    -9.8 ± 0.728
    -11.7 ± 0.731
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Change from Baseline at Day 3
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6912
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 1.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.649
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Change from Baseline at Day 8
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.041
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.874
    Statistical analysis title
    		 Statistical Analysis 5
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1846
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.987
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Change from Baseline at Day 21
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0811
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.924
    Statistical analysis title
    		 Statistical Analysis 6
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0625
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.031
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Change from Baseline at Day 15
    Comparison groups
    Placebo v Sage 217 50 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0444
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.922

    Secondary: Percentage of Subjects With at Least One Treatment-Emergent Adverse Event (TEAE)

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    End point title
    		 Percentage of Subjects With at Least One Treatment-Emergent Adverse Event (TEAE)
    End point description
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subjects administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset after the start of Investigational Product (IP), or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Safety Set included all participants who were administered IP.
    End point type
    Secondary
    End point timeframe
    Up to Day 45
    End point values
    		 Placebo Sage 217 50 mg
    Number of subjects analysed
    98
    98
    Units: percentage of participants
        number (not applicable)
    53.1
    66.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline up to Day 45
    Adverse event reporting additional description
    Safety Set included all subjects who were administered IP.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    SAGE-217 50 mg
    Reporting group description
    		 Subjects received SAGE-217, 50 mg, capsules, orally, once daily for 14 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received SAGE-217 matched-placebo capsules, orally, once daily for 14 days.

    Serious adverse events
    		 SAGE-217 50 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 98 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Perinatal depression
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (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
    		 SAGE-217 50 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 98 (66.33%)
    52 / 98 (53.06%)
    Investigations
    Blood triglycerides increased
         subjects affected / exposed
    1 / 98 (1.02%)
    4 / 98 (4.08%)
         occurrences all number
    1
    4
    Urine leukocyte esterase positive
         subjects affected / exposed
    0 / 98 (0.00%)
    3 / 98 (3.06%)
         occurrences all number
    0
    4
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 98 (1.02%)
    2 / 98 (2.04%)
         occurrences all number
    1
    3
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    White blood cells urine positive
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    Blood urine present
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    Red blood cells urine positive
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    Nitrite urine present
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    13 / 98 (13.27%)
    10 / 98 (10.20%)
         occurrences all number
    19
    11
    Headache
         subjects affected / exposed
    9 / 98 (9.18%)
    13 / 98 (13.27%)
         occurrences all number
    16
    39
    Somnolence
         subjects affected / exposed
    26 / 98 (26.53%)
    5 / 98 (5.10%)
         occurrences all number
    33
    5
    Sedation
         subjects affected / exposed
    11 / 98 (11.22%)
    1 / 98 (1.02%)
         occurrences all number
    12
    1
    Memory impairment
         subjects affected / exposed
    3 / 98 (3.06%)
    0 / 98 (0.00%)
         occurrences all number
    3
    0
    Hypoaesthesia
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Tremor
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    4 / 98 (4.08%)
    1 / 98 (1.02%)
         occurrences all number
    4
    1
    Fatigue
         subjects affected / exposed
    3 / 98 (3.06%)
    1 / 98 (1.02%)
         occurrences all number
    3
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 98 (6.12%)
    2 / 98 (2.04%)
         occurrences all number
    8
    3
    Nausea
         subjects affected / exposed
    5 / 98 (5.10%)
    6 / 98 (6.12%)
         occurrences all number
    12
    6
    Abdominal pain
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Dry mouth
         subjects affected / exposed
    2 / 98 (2.04%)
    3 / 98 (3.06%)
         occurrences all number
    2
    3
    Constipation
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 98 (2.04%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    3 / 98 (3.06%)
    1 / 98 (1.02%)
         occurrences all number
    4
    1
    Musculoskeletal and connective tissue disorders
    Muscle twitching
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Myalgia
         subjects affected / exposed
    3 / 98 (3.06%)
    0 / 98 (0.00%)
         occurrences all number
    3
    0
    Back pain
         subjects affected / exposed
    1 / 98 (1.02%)
    2 / 98 (2.04%)
         occurrences all number
    2
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    5 / 98 (5.10%)
    0 / 98 (0.00%)
         occurrences all number
    5
    0
    Urinary tract infection
         subjects affected / exposed
    5 / 98 (5.10%)
    4 / 98 (4.08%)
         occurrences all number
    5
    4
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jan 2021
    The summary of Amendment 1 was as follows: - Added COVID-19 questions to be asked to document information regarding diagnosis, isolation, and/or hospitalization due to COVID-19 as part of medical history, AE collection, and prior/concomitant medication/procedure collection throughout the study; - Broadened the eligibility criteria to include women who were up to 12 months postpartum. The criterion for the diagnosis of PPD, including the onset of symptoms, remained the same per DSM-5. The extension to 12 months was instituted so that a broader population of subjects could be reached, consistent with DSM-5; -Clarified that a subject with an index pregnancy that resulted in neonatal/infant death would be excluded; -Added details on the estimand specified in the protocol per FDA request; -Removed the definition of overdose to align with current Sage practice and other protocols. Cases of overdose were to be collected as reported by the investigator and recorded as an AE; -Increased the number of sites where the study was to be conducted; -Indicated that urine and serum pregnancy tests were to be conducted at Screening and that the urine test was recommended to precede other Screening assessments. Qualifying criteria were to be based on serum test results; - Updated contraception requirements to specify the types of bilateral tubal occlusion procedures that were considered to be acceptable forms of contraception and which procedure type required at least 3 months postprocedure prior to Screening; -Aligned the prohibited medication section with medications listed as exclusion criteria.

    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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