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    Clinical Trial Results:
    A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Flexible- Dosed Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents with Autistic Disorder.

    Summary
    EudraCT number
    		 2016-005111-40
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Apr 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Apr 2018
    First version publication date
    21 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CN138178
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00365859
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 71,501
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Wallingford, Connecticut, United States, 06492
    Public contact
    Angela Smith, Otsuka Pharmaceutical Development & Commercialization, Inc, =1 8609202209, angela.smith@otsuka-us.com
    Scientific contact
    Angela Smith, Otsuka Pharmaceutical Development & Commercialization, Inc, =1 8609202209, angela.smith@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
    21 Oct 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Apr 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Apr 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of flexibly dosed aripiprazole with that of placebo in reducing serious behavioral problems specifically irritability, agitation, and self-injurious behavior in children and adolescents with a diagnosis of AD, as measured by change from baseline to endpoint on the Irritability Subscale of the Aberrant Behavior Checklist (ABC).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles in the Declaration of Helsinki. The rights, safety, and well-being of the study subjects were the most important consideration and prevailed over the interests of science and society. This study was conducted in accordance with Good Clinical Practice, as defined by the International Conference on Harmonization and in accordance with the ethical principles underlying European Union Directive 2001/20/EC and the United States Code of Federal Regulations, Title 21, Part 50 (21CFR50).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 98
    Worldwide total number of subjects
    98
    EEA total number of subjects
    0
    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)
    77
    Adolescents (12-17 years)
    21
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 164 patients were enrolled at 19 study centers in the United States. The test product was aripiprazole, 2 to 15 mg/day, flexibly dosed. The reference product was placebo.

    Pre-assignment
    Screening details
    		 Screening phase (up to 42 days (consisting of a screening visit (Visit 1), a washout period and interim screening visit (Visit 1a) , and a baseline visit (Visit 2)). During screening eligibility assessments, safety assessments, efficacy assessments and clinical drug supplies were performed.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Aripiprazole tablets and placebo tablets were indistinguishable in appearance and shape. Study medication for the 2 treatment groups looked identical. Bottles of study medication were labeled with a 3-panel, double-blind label. The labels contained information such as the batch number, container number, number of tablets per bottle, and storage conditions.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Aripiprazole
    Arm description
    		 Aripiprazole (oral tablet) flexibly dosed (2 mg to 15 mg/day) taken once daily at the same time each day without regard to meals for 8 weeks. Approximately 100 patients (50 per treatment group) will be randomized to obtain 90 evaluable patients (45 per treatment arm).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aripiprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All randomized patients received test product aripiprazole at flexible dosing regimen (2 to 15 mg/day) for 8 weeks on the basis of treatment response and medication tolerability. Aripiprazole was given orally at a starting dose of 2 mg. The target daily dose was 5 mg, 10 mg, or 15 mg. The need of increase in dose was done based on the clinical response and tolerability.

    Arm title
    		 Placebo
    Arm description
    		 Randomized patients were treated orally once daily with the matching placebo tablets.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All randomized patients received matching placebo (oral tablet) at flexible dosing regimen once daily at the same time each day for 8 weeks.

    Number of subjects in period 1
    		Aripiprazole Placebo
    Started
    47
    51
    Completed
    39
    36
    Not completed
    8
    15
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    5
    3
         Lost to follow-up
    1
    4
         Lack of efficacy
    1
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Aripiprazole
    Reporting group description
    		 Aripiprazole (oral tablet) flexibly dosed (2 mg to 15 mg/day) taken once daily at the same time each day without regard to meals for 8 weeks. Approximately 100 patients (50 per treatment group) will be randomized to obtain 90 evaluable patients (45 per treatment arm).

    Reporting group title
    Placebo
    Reporting group description
    		 Randomized patients were treated orally once daily with the matching placebo tablets.

    Reporting group values
    		 Aripiprazole Placebo Total
    Number of subjects
    		 47 51 98
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 33 44 77
        Adolescents (12-17 years)
    		 14 7 21
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 5 7 12
        Male
    		 42 44 86

    End points

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    End points reporting groups
    Reporting group title
    Aripiprazole
    Reporting group description
    		 Aripiprazole (oral tablet) flexibly dosed (2 mg to 15 mg/day) taken once daily at the same time each day without regard to meals for 8 weeks. Approximately 100 patients (50 per treatment group) will be randomized to obtain 90 evaluable patients (45 per treatment arm).

    Reporting group title
    Placebo
    Reporting group description
    		 Randomized patients were treated orally once daily with the matching placebo tablets.

    Primary: Aberrant Behavior Checklist (ABC) irritability subscale score

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    End point title
    		 Aberrant Behavior Checklist (ABC) irritability subscale score
    End point description
    To assess the efficacy of flexibly dosed aripiprazole with that of placebo, measured by mean change from baseline to endpoint (Week 8) in the ABC Irritability Subscale score. The ABC is an informant based symptom checklist for assessing the classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolved into 5 subscales: (1) irritability, agitation; (2) lethargy, social withdrawal; (3) stereotypic behavior; (4) hyperactivity, noncompliance; and (5) inappropriate speech.
    End point type
    Primary
    End point timeframe
    From screening phase (visit 1 and baseline visit 2 [up to 42 days]) to treatment phase (Week 1 to week 8).
    End point values
    		 Aripiprazole Placebo
    Number of subjects analysed
    46
    49
    Units: number
    arithmetic mean (standard error)
        Mean baseline (SE)
    29.6 ( 1.01 )
    30.8 ( 1 )
        Mean change week 8 (SE)
    -12.9 ( 1.44 )
    -5 ( 1.43 )
    Statistical analysis title
    		 Treatment difference from Placebo
    Comparison groups
    Aripiprazole v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Median difference (final values)
    Point estimate
    -7.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.7
         upper limit
    		 -4.1

    Secondary: Aberrant Behavior Checklist (ABC) other subscale score

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    End point title
    		 Aberrant Behavior Checklist (ABC) other subscale score
    End point description
    To assess the efficacy of flexibly dosed aripiprazole with that of placebo, measured by mean change from baseline to endpoint (Week 8) in the ABC Irritability Subscale score. The ABC is an informant-based symptom checklist for assessing the classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolved into 5 subscales: (1) irritability, agitation; (2) lethargy, social withdrawal; (3) stereotypic behavior; (4) hyperactivity, noncompliance; and (5) inappropriate speech.
    End point type
    Secondary
    End point timeframe
    From screening phase (visit 1 and baseline visit 2 [up to 42 days]) to treatment phase (Week 1 to week 8).
    End point values
    		 Aripiprazole Placebo
    Number of subjects analysed
    46
    49
    Units: Number
    arithmetic mean (standard error)
        ABC Hyperactivity Subscale Score is from 0 to 48.
    -12.7 ( 1.52 )
    -2.8 ( 1.5 )
        ABC Stereotypy Subscale Score is from 0 to 21.
    -4.8 ( 0.63 )
    -2 ( 0.62 )
        ABCInappropriateSpeechSubscaleScore is from0 to 12
    -2.5 ( 0.39 )
    -0.4 ( 0.39 )
        ABCSocialWithdrawal Subscale Score is from 0 to 48
    -7.9 ( 1.15 )
    -6.2 ( 1.13 )
    Statistical analysis title
    		 Treatment difference from Placebo
    Comparison groups
    Aripiprazole v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.001 [2]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.7
         upper limit
    		 -4.1
    Notes
    [1] - The primary presentation of results will be the model-based estimates and standard errors (SE) and the 95% confidence intervals (CI) for the treatment differences (aripiprazole-placebo), which will be derived from the estimation (ESTIMATE) of the treatment contrast.
    [2] - P-values were two-tailed tests of significance rounded to three decimal places, based on ANOVA/ANCOVA model.

    Secondary: Clinical Global Impression of Severity (CGI-S)

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    End point title
    		 Clinical Global Impression of Severity (CGI-S)
    End point description
    To assess the efficacy of aripiprazole with placebo as measured by the clinician-rated Clinical Global Impression of Improvement (CGI-I) and Clinical Global Impression of Severity (CGI-S). At baseline, a CGI Severity of Illness (CGI-S) assessment is performed, in which the clinician rates the severity of a patient’s condition on a 7-point scale ranging from 1 (no symptoms) to 7 (very severe symptoms). At subsequent visits, the clinician assesses the patient’s improvement relative to the symptoms at baseline on a CGI-Improvement (CGI-I) item, a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
    End point type
    Secondary
    End point timeframe
    Treatment phase (Visit 3 to visit 9 or early discontinuation).
    End point values
    		 Aripiprazole Placebo
    Number of subjects analysed
    46
    49
    Units: Number
    arithmetic mean (standard error)
        CGI-S score (participant number=40,40)
    -1.2 ( 0.14 )
    -0.4 ( 0.15 )
        CGI-I score (participant number=46,49)
    2.2 ( 0.18 )
    3.6 ( 0.18 )
    Statistical analysis title
    		 Treatment difference from Placebo (CGI-S)
    Comparison groups
    Aripiprazole v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.001 [4]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.4
    Notes
    [3] - The primary presentation of results will be the model-based estimates and standard errors (SE) and the 95% confidence intervals (CI) for the treatment differences (aripiprazole-placebo), which will be derived from the estimation (ESTIMATE) of the treatment contrast.
    [4] - P-values were two-tailed tests of significance rounded to three decimal places, based on ANOVA/ANCOVA model.
    Statistical analysis title
    		 Treatment difference from Placebo (CGI-I)
    Comparison groups
    Placebo v Aripiprazole
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Median difference (final values)
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 -1

    Secondary: Response rate at week 8

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    End point title
    		 Response rate at week 8
    End point description
    Response rate, defined as a reduction of ≥ 25% in ABC Irritability Subscale score compared to baseline and a score of 1 or 2 in the CGI-I scale, was determined at Weeks 1 through week 8 of the study.
    End point type
    Secondary
    End point timeframe
    From week 1 through week 8.
    End point values
    		 Aripiprazole Placebo
    Number of subjects analysed
    46
    49
    Units: percentage
    number (not applicable)
        Number Responding (%)
    24
    7
    Statistical analysis title
    		 Response rate vs Placebo
    Comparison groups
    Aripiprazole v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    3.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 7.7

    Secondary: Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

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    End point title
    		 Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
    End point description
    The CY-BOCS is a 10-item, clinician-rated scale based on a semi-structured interview that was designed to measure the severity of obsessive-compulsive symptoms in patients below the age of 18. The CY-BOCS contains 5 items pertaining to obsessions (which will not be used in this trial) and 5 items pertaining to compulsions, which rate each symptom domain in terms of time spent, interference with functioning, distress, resistance, and control. Each item is rated on a 5-point scale, from 0 (no symptoms or minimum severity) to 4 (extreme symptoms or maximum severity).
    End point type
    Secondary
    End point timeframe
    At week 8.
    End point values
    		 Aripiprazole Placebo
    Number of subjects analysed
    43
    44
    Units: Mean
    arithmetic mean (standard error)
        Mean Baseline (SE)
    12.8 ( 0.46 )
    13.7 ( 0.48 )
        Mean Change Week 8 (SE)
    -3.8 ( 0.5 )
    -0.8 ( 0.52 )
    Statistical analysis title
    		 Difference from Placebo
    Comparison groups
    Aripiprazole v Placebo
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 < 0.001 [6]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 -1.6
    Notes
    [5] - The primary presentation of results will be the model-based estimates and standard errors (SE) and the 95% confidence intervals (CI) for the treatment differences (aripiprazole-placebo), which will be derived from the estimation (ESTIMATE) of the treatment contrast.
    [6] - P-values were two-tailed tests of significance rounded to three decimal places, based on ANOVA/ANCOVA model.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment period and or early discontinuation.
    Adverse event reporting additional description
    An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11
    Reporting groups
    Reporting group title
    Aripiprazole
    Reporting group description
    		 Aripiprazole 2-mg, 5-mg, 10-mg, or 15-mg tablets, orally, once a day, with a starting dose of 2 mg and a target dose of 5 mg, 10 mg, or 15 mg.

    Reporting group title
    Placebo
    Reporting group description
    		 At the baseline visit, eligible patients were randomized to receive either aripiprazole or placebo according to a computer-generated randomization schedule prepared by BMS using a permuted block design. Treatment assignments were governed by a randomization schedule designed to allocate patients between the 2 treatment arms in a 1:1 ratio.

    Serious adverse events
    		 Aripiprazole Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Aripiprazole Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 47 (91.49%)
    36 / 50 (72.00%)
    Nervous system disorders
    Drooling
         subjects affected / exposed
    4 / 47 (8.51%)
    0 / 50 (0.00%)
         occurrences all number
    5
    0
    Headache
         subjects affected / exposed
    3 / 47 (6.38%)
    8 / 50 (16.00%)
         occurrences all number
    3
    11
    Sedation
         subjects affected / exposed
    5 / 47 (10.64%)
    1 / 50 (2.00%)
         occurrences all number
    9
    1
    Somnolence
         subjects affected / exposed
    8 / 47 (17.02%)
    2 / 50 (4.00%)
         occurrences all number
    14
    3
    Tremor
         subjects affected / exposed
    4 / 47 (8.51%)
    0 / 50 (0.00%)
         occurrences all number
    5
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    10 / 47 (21.28%)
    2 / 50 (4.00%)
         occurrences all number
    15
    3
    Pyrexia
         subjects affected / exposed
    4 / 47 (8.51%)
    1 / 50 (2.00%)
         occurrences all number
    5
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 47 (8.51%)
    5 / 50 (10.00%)
         occurrences all number
    6
    9
    Vomiting
         subjects affected / exposed
    7 / 47 (14.89%)
    2 / 50 (4.00%)
         occurrences all number
    9
    2
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 50 (2.00%)
         occurrences all number
    5
    1
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 50 (8.00%)
         occurrences all number
    4
    5
    Enuresis
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 50 (8.00%)
         occurrences all number
    3
    4
    Insomnia
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 50 (8.00%)
         occurrences all number
    6
    7
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 47 (4.26%)
    3 / 50 (6.00%)
         occurrences all number
    2
    4
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 47 (2.13%)
    5 / 50 (10.00%)
         occurrences all number
    2
    8
    Metabolism and nutrition disorders
    increased appetitie
         subjects affected / exposed
    7 / 47 (14.89%)
    5 / 50 (10.00%)
         occurrences all number
    11
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Dec 2006
    • Decreased the screening washout period for patients from 2 weeks to 4 days. • Removed the requirement that sites have separate raters for safety and efficacy assessments. • Added the Pediatric Quality of Life Inventory with age-appropriate versions and the Caregiver Strain Questionnaire outcome measure scales to the protocol. • Clarified the requirements for mental age.
    14 Jun 2007
    • Decreased the number of days, after the last dose of study drug, that an efficacy evaluation will be included for analysis. • Specified that there must be documentation that confirms the mental age. • Added the use of a historical ADI-R as long as it was completed by a documented research reliable ADI-R rater. • Added height to the Baseline Visit. • Added the laboratory collection and evaluation of insulin. • Extended the enrollment period of the study from approximately 18 months to approximately 26 months. • Clarified that efficacy data will be reviewed by the Data Monitoring Committee but that these data will not be used to stop the trial. • Deleted the administration of the CY-BOCS from the list of Screening Visit requirements. • Added mental age assessment as a procedure that must be completed at the Baseline Visit if it was not done at a Screening Visit. • Corrected the amount of time, after the end of the study, a woman of childbearing potential must use an adequate method of contraception, to make the time periods consistent within this protocol and the other double-blind protocol. • Updated the medical monitor’s contact information. • Revised the wording of Reference 17 to be consistent with the reference in the other double-blind protocol. • Added a new reference for establishing an research reliable ADI-R rater. • Corrected typographical errors. • Updated SAE facsimile number

    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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    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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