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    Clinical Trial Results:
    A Multicenter, Randomized, Flexible-dose, Double-blind Trial of Brexpiprazole Versus Placebo for the Treatment of Adults With Borderline Personality Disorder

    Summary
    EudraCT number
    		 2019-002813-20
    Trial protocol
    		 DE   ES  
    Global end of trial date
    27 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2022
    First version publication date
    13 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    331-201-00242
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04100096
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Otsuka Pharmaceutical Development & Commercialization, Inc.
    Sponsor organisation address
    2440 Research Boulevard, Rockville, United States, 20850
    Public contact
    Clinical Transparency, Otsuka Pharmaceutical Development & Commercialization, Inc., clinicaltransparency@otsuka-us.com
    Scientific contact
    Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., clinicaltransparency@otsuka-us.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
    27 Jun 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of brexpiprazole versus placebo for the treatment of subjects with a diagnosis of borderline personality disorder (BPD).
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Oct 2019
    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
    Ukraine: 15
    Country: Number of subjects enrolled
    United States: 308
    Country: Number of subjects enrolled
    Spain: 9
    Worldwide total number of subjects
    332
    EEA total number of subjects
    9
    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)
    332
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled in the study at 62 study centres in the United States, Spain, and Ukraine from 17 October 2019 to 27 June 2021.

    Pre-assignment
    Screening details
    		 332 subjects were enrolled out of which 324 subjects were randomised to receive brexpiprazole or matching placebo in the treatment phase.

    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, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Brexpiprazole 2-3 Milligrams Per Day
    Arm description
    		 Subjects received brexpiprazole, 2-3 milligrams per day (mg/day) tablets, orally, up to Week 12 during the treatment phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brexpiprazole
    Investigational medicinal product code
    OPC-34712
    Other name
    Rexulti®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Brexpiprazole tablets, administered orally, 2-3 mg/day up to Week 12 during the treatment phase.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received brexpiprazole-matching placebo tablets, orally, up to Week 12 during the treatment phase.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Brexpiprazole-matching placebo tablets, administered orally, up to Week 12 during the treatment phase.

    Number of subjects in period 1 [1]
    		Brexpiprazole 2-3 Milligrams Per Day Placebo
    Started
    159
    165
    Safety Population
    157
    165
    Full Analysis Set for Enriched Subjects
    110 [2]
    110 [3]
    Completed
    112
    127
    Not completed
    47
    38
         Non-Compliance With Study Drug
    1
    3
         Adverse event
    19
    7
         Lost to follow-up
    13
    11
         Protocol deviation
    1
    1
         Withdrawal by subject
    13
    15
         Lack of efficacy
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline data is reported for the randomised population which include all subjects who were randomised to receive brexpiprazole or matching placebo in the treatment phase.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Safety population include subjects who received at least 1 dose of study drug (brexpiprazole or placebo). Full analysis set for enriched subjects is a subset of randomised population who met pre-defined criteria and who received at least 1 dose of double-blind investigational medicinal product (IMP) and had baseline value and at least 1 valid post-randomisation efficacy evaluation for ZAN-BPD total score.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Safety population include subjects who received at least 1 dose of study drug (brexpiprazole or placebo). Full analysis set for enriched subjects is a subset of randomised population who met pre-defined criteria and who received at least 1 dose of double-blind investigational medicinal product (IMP) and had baseline value and at least 1 valid post-randomisation efficacy evaluation for ZAN-BPD total score.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Brexpiprazole 2-3 Milligrams Per Day
    Reporting group description
    		 Subjects received brexpiprazole, 2-3 milligrams per day (mg/day) tablets, orally, up to Week 12 during the treatment phase.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received brexpiprazole-matching placebo tablets, orally, up to Week 12 during the treatment phase.

    Reporting group values
    		 Brexpiprazole 2-3 Milligrams Per Day Placebo Total
    Number of subjects
    		 159 165 324
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.0 ( 10.6 ) 31.0 ( 10.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 129 137 266
        Male
    		 30 28 58
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 3 0 3
        Asian
    		 7 2 9
        Native Hawaiian or Other Pacific Islander
    		 1 1 2
        Black or African American
    		 19 22 41
        White
    		 123 131 254
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 6 9 15
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 31 33 64
        Not Hispanic or Latino
    		 127 131 258
        Unknown
    		 1 0 1
        Other
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Brexpiprazole 2-3 Milligrams Per Day
    Reporting group description
    		 Subjects received brexpiprazole, 2-3 milligrams per day (mg/day) tablets, orally, up to Week 12 during the treatment phase.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received brexpiprazole-matching placebo tablets, orally, up to Week 12 during the treatment phase.

    Primary: Change From Baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score

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    End point title
    		 Change From Baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score
    End point description
    A clinician-administered scale with a total score range of 0 to 36. A higher score represents a higher severity of disease symptoms. Mixed model repeated measures=MMRM, antidepressant therapy=ADT. Full analysis set (FAS) for enriched subjects= subset of randomised population who met pre-defined criteria and who received at least 1 dose of double-blind investigational medicinal product (IMP) and had baseline value and at least 1 valid post-randomisation efficacy evaluation for ZAN-BPD total score.
    End point type
    Primary
    End point timeframe
    Change from Baseline
    End point values
    		 Brexpiprazole 2-3 Milligrams Per Day Placebo
    Number of subjects analysed
    110
    110
    Units: score on a scale
        least squares mean (standard error)
    -7.27 ( 0.80 )
    -6.25 ( 0.76 )
    Statistical analysis title
    		 Brexpiprazole vs Placebo
    Comparison groups
    Brexpiprazole 2-3 Milligrams Per Day v Placebo
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.243 [1]
    Method
    		 MMRM
    Parameter type
    		 Least Square (LS) Mean Difference
    Point estimate
    -1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.75
         upper limit
    		 0.7
    Notes
    [1] - Comparison was carried out using MMRM, with study centre (pooled), treatment group (TG), visit, ADT status, and TG by visit interaction (BVI), gender BVI, age BVI as factors and baseline BVI as covariate. An unstructured covariance was used.

    Secondary: Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score

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    End point title
    		 Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score
    End point description
    The severity of illness for each subject was rated using the CGI-S. CGI-S is an observer-rated scale with a total score range of 0 to 7 where a higher score represented a worse outcome. The response choices were 0 = not assessed; 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill subjects. FAS for enriched subjects is a subset of randomised population who met pre-defined criteria and who received at least 1 dose of double-blind IMP and had a baseline value and at least 1 valid post-randomisation efficacy evaluation for ZAN-BPD total score.
    End point type
    Secondary
    End point timeframe
    Change from Baseline
    End point values
    		 Brexpiprazole 2-3 Milligrams Per Day Placebo
    Number of subjects analysed
    110
    110
    Units: score on a scale
        least squares mean (standard error)
    -1.13 ( 0.14 )
    -1.09 ( 0.14 )
    Statistical analysis title
    		 Brexpiprazole vs Placebo
    Comparison groups
    Brexpiprazole 2-3 Milligrams Per Day v Placebo
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7759 [2]
    Method
    		 MMRM
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.35
         upper limit
    		 0.27
    Notes
    [2] - Comparison was carried out using MMRM, with study centre (pooled), TG, visit, ADT status, and TG BVI, gender BVI, age BVI as factors and baseline BVI as covariate. An unstructured covariance was used.

    Secondary: Clinical Global Impression - Improvement (CGI-I) Scale Score

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    End point title
    		 Clinical Global Impression - Improvement (CGI-I) Scale Score
    End point description
    Subject's condition was assessed using CGI-I scale. CGI-I is an observer-rated scale with a total score of 0 to 7 and a higher score represents a worse outcome. The score included the following response choices: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill subjects. FAS for enriched subjects is a subset of randomised population who met pre-defined criteria and who received at least 1 dose of double-blind IMP and had a baseline value and at least 1 valid post-randomisation efficacy evaluation for ZAN-BPD total score. n = number of subjects with data available for analyses at the specified time point.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, 8, 10 and 12
    End point values
    		 Brexpiprazole 2-3 Milligrams Per Day Placebo
    Number of subjects analysed
    110
    110
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 2 (n=110, 109)
    2.99 ( 0.96 )
    2.99 ( 0.97 )
        Week 4 (n=110, 110)
    2.89 ( 1.04 )
    3.00 ( 1.20 )
        Week 6 (n=110, 110)
    2.62 ( 1.05 )
    2.77 ( 1.21 )
        Week 8 (n=110, 110)
    2.39 ( 1.06 )
    2.79 ( 1.26 )
        Week 10 (n=110, 110)
    2.45 ( 1.18 )
    2.61 ( 1.20 )
        Week 12 (n=110, 110)
    2.37 ( 1.19 )
    2.65 ( 1.17 )
    Statistical analysis title
    		 Week 2: Brexpiprazole vs Placebo
    Comparison groups
    Brexpiprazole 2-3 Milligrams Per Day v Placebo
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6579 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 0.19
    Notes
    [3] - Comparison between TGs was carried out using the Cochran-Mantel-Haenszel (CMH) Row Mean Score Differ Test controlling for trial site.
    Statistical analysis title
    		 Week 4: Brexpiprazole vs Placebo
    Comparison groups
    Brexpiprazole 2-3 Milligrams Per Day v Placebo
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3728 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.16
    Notes
    [4] - Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.
    Statistical analysis title
    		 Week 6: Brexpiprazole vs Placebo
    Comparison groups
    Brexpiprazole 2-3 Milligrams Per Day v Placebo
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1684 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.09
    Notes
    [5] - Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.
    Statistical analysis title
    		 Week 8: Brexpiprazole vs Placebo
    Comparison groups
    Brexpiprazole 2-3 Milligrams Per Day v Placebo
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0046 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.74
         upper limit
    		 -0.13
    Notes
    [6] - Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.
    Statistical analysis title
    		 Week 10: Brexpiprazole vs Placebo
    Comparison groups
    Brexpiprazole 2-3 Milligrams Per Day v Placebo
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2087 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.51
         upper limit
    		 0.11
    Notes
    [7] - Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.
    Statistical analysis title
    		 Week 12: Brexpiprazole vs Placebo
    Comparison groups
    Brexpiprazole 2-3 Milligrams Per Day v Placebo
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0389 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.64
         upper limit
    		 -0.02
    Notes
    [8] - Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable 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 that started after start of study treatment. Safety population (SP): Subjects who received at least 1 dose of study drug (brexpiprazole or placebo).
    End point type
    Secondary
    End point timeframe
    From Baseline to 21 days after last dose (up to Week 15)
    End point values
    		 Brexpiprazole 2-3 Milligrams Per Day Placebo
    Number of subjects analysed
    157
    165
    Units: subjects with TEAEs
    95
    79
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline to 21 days after last dose (up to Week 15)
    Adverse event reporting additional description
    Safety population included randomised subjects who received at least 1 dose of study drug (brexpiprazole or placebo).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Brexpiprazole 2-3 Milligrams Per Day
    Reporting group description
    		 Subjects received brexpiprazole, 2-3 mg/day tablets, orally, up to Week 12 during the treatment phase.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received brexpiprazole-matching placebo tablets, orally, up to Week 12 during the treatment phase.

    Serious adverse events
    		 Brexpiprazole 2-3 Milligrams Per Day Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 157 (3.18%)
    2 / 165 (1.21%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Dissociation
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major Depression
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic Attack
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    2 / 157 (1.27%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Brexpiprazole 2-3 Milligrams Per Day Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    69 / 157 (43.95%)
    45 / 165 (27.27%)
    Investigations
    Weight Increased
         subjects affected / exposed
    10 / 157 (6.37%)
    4 / 165 (2.42%)
         occurrences all number
    10
    4
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    22 / 157 (14.01%)
    2 / 165 (1.21%)
         occurrences all number
    27
    3
    Headache
         subjects affected / exposed
    8 / 157 (5.10%)
    12 / 165 (7.27%)
         occurrences all number
    8
    13
    Somnolence
         subjects affected / exposed
    8 / 157 (5.10%)
    5 / 165 (3.03%)
         occurrences all number
    9
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    12 / 157 (7.64%)
    6 / 165 (3.64%)
         occurrences all number
    13
    6
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    13 / 157 (8.28%)
    9 / 165 (5.45%)
         occurrences all number
    16
    9
    Insomnia
         subjects affected / exposed
    15 / 157 (9.55%)
    10 / 165 (6.06%)
         occurrences all number
    15
    11
    Restlessness
         subjects affected / exposed
    10 / 157 (6.37%)
    2 / 165 (1.21%)
         occurrences all number
    10
    2
    Metabolism and nutrition disorders
    Increased Appetite
         subjects affected / exposed
    8 / 157 (5.10%)
    4 / 165 (2.42%)
         occurrences all number
    8
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jul 2020
    The purpose of this protocol amendment was to introduce a COVID-19 Addendum for any protocol-specified activities that were not able to be performed per protocol or could not be performed due to COVID-19 considerations.

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

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

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