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    Clinical Trial Results:
    A 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Donepezil hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome

    Summary
    EudraCT number
    		 2016-004946-27
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    05 Sep 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 May 2021
    First version publication date
    23 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    E2020-A001-219
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00570128
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eisai Medical Research Inc.
    Sponsor organisation address
    100 Tice Boulevard, Woodcliff Lake, New Jersey, United States, 07677
    Public contact
    Eisai Medical Information, Eisai Inc., 011 888274-2378, esi_medinfo@eisai.com
    Scientific contact
    Eisai Medical Information, Eisai Inc., 011 888274-2378, esi_medinfo@eisai.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Sep 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine whether donepezil hydrochloride (HCl) is effective and safe in improving cognitive dysfunction exhibited by children and adolescents with Down syndrome (DS). Effectiveness will be measured by rating communication, daily living skills, and social skills and relationships in subjects aged 12 to 17.
    Protection of trial subjects
    This study was conducted in accordance with standard operating procedures (SOPs) of the sponsor (or designee), which are designed to ensure adherence to Good Clinical Practice (GCP) guidelines as required by the following: - Principles of the World Medical Association Declaration of Helsinki (World Medical Association, 2008) - International Council on Harmonisation (ICH) E6 Guideline for GCP (CPMP/ICH/135/95) of the European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products, International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - Title 21 of the United States (US) Code of Federal Regulations (US 21 CFR) regarding clinical studies, including Part 50 and Part 56 concerning informed subject consent and Institutional Review Board (IRB) regulations and applicable sections of US 21 CFR Part 312 - European Good Clinical Practice Directive 2005/28/EC and Clinical Trial Directive 2001/20/EC for studies conducted within any European Union (EU) country. All suspected unexpected serious adverse reactions were reported, as required, to the Competent Authorities of all involved EU member states. - Article 14, Paragraph 3, and Article 80-2 of the Pharmaceutical Affairs Law (Law No. 145, 1960) for studies conducted in Japan, in addition to Japan’s GCP Subject Information and Informed Consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Nov 2007
    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: 129
    Worldwide total number of subjects
    129
    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)
    0
    Adolescents (12-17 years)
    129
    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
    		 This study was conducted at 35 centers in the United States during the period of 16 November 2007 to 05 September 2008.

    Pre-assignment
    Screening details
    		 A total of 158 subjects were screened, of which 29 were screen failures and 129 subjects were randomized to receive 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
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Donepezil HCl
    Arm description
    		 Blinded donepezil hydrochloride (HCl) 2.5 milligram per day (mg/day) (2.5 milliliter per day [mL/day]) orally for subjects with body weight (BW) 20 and less than (<) 25 kilogram (kg), 5 mg/day (5 mL/day) orally for subjects with BW 25 to <50 kg, and 10 mg/day (10 mL/day) orally for subjects with BW greater than or equal to (>=) 50 kg liquid formulation (1 milligram per 1 milliliter [1 mg/1 mL]) (titrated to 0.1 to 0.2 milligram per kilogram per day [mg/kg/day] based on BW).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Donepezil HCl
    Investigational medicinal product code
    Other name
    Aricept
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Blinded donepezil HCl 2.5 mg/day (2.5 mL/day) orally for subjects with BW 20 and <25 kg, 5 mg/day (5 mL/day) orally for subjects with BW 25 to <50 kg, and 10 mg/day (10 mL/day) orally for subjects with BW >=50 kg liquid formulation (1 mg/1 mL) (titrated to 0.1 to 0.2 mg/kg/day based on BW).

    Arm title
    		 Placebo
    Arm description
    		 Liquid formulation matched to active treatment for oral administration.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Liquid formulation matched to active treatment for oral administration.

    Number of subjects in period 1
    		Donepezil HCl Placebo
    Started
    64
    65
    Completed
    60
    65
    Not completed
    4
    0
         Consent withdrawn by subject
    2
    -
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Donepezil HCl
    Reporting group description
    		 Blinded donepezil hydrochloride (HCl) 2.5 milligram per day (mg/day) (2.5 milliliter per day [mL/day]) orally for subjects with body weight (BW) 20 and less than (<) 25 kilogram (kg), 5 mg/day (5 mL/day) orally for subjects with BW 25 to <50 kg, and 10 mg/day (10 mL/day) orally for subjects with BW greater than or equal to (>=) 50 kg liquid formulation (1 milligram per 1 milliliter [1 mg/1 mL]) (titrated to 0.1 to 0.2 milligram per kilogram per day [mg/kg/day] based on BW).

    Reporting group title
    Placebo
    Reporting group description
    		 Liquid formulation matched to active treatment for oral administration.

    Reporting group values
    		 Donepezil HCl Placebo Total
    Number of subjects
    		 64 65 129
    Age categorical
    Individual subject ages were not available for this study so the categorical age breakdown in the Trial Information Section could not be populated. Instead, all subjects were reported in the ‘Adolescents (12-17 years)’ category. The categorical age breakdown available (10 to 13 years and 14 to 17 years) is reported below.
    Units: subjects
        10 to 13 years
    		 41 38 79
        14 to 17 years
    		 23 27 50
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.0 ( 2.3 ) 13.0 ( 2.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 28 35 63
        Male
    		 36 30 66
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 1 4 5
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 3 3 6
        White
    		 54 57 111
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 6 1 7

    End points

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    End points reporting groups
    Reporting group title
    Donepezil HCl
    Reporting group description
    		 Blinded donepezil hydrochloride (HCl) 2.5 milligram per day (mg/day) (2.5 milliliter per day [mL/day]) orally for subjects with body weight (BW) 20 and less than (<) 25 kilogram (kg), 5 mg/day (5 mL/day) orally for subjects with BW 25 to <50 kg, and 10 mg/day (10 mL/day) orally for subjects with BW greater than or equal to (>=) 50 kg liquid formulation (1 milligram per 1 milliliter [1 mg/1 mL]) (titrated to 0.1 to 0.2 milligram per kilogram per day [mg/kg/day] based on BW).

    Reporting group title
    Placebo
    Reporting group description
    		 Liquid formulation matched to active treatment for oral administration.

    Primary: Mean Change From Baseline in V-Scale Composite Score (Sum of 9 Sub-Domains) of Vineland Adaptive Behavior Scales Second Edition-Parent Caregiver Rating Form (VABS-II/PCRF) at Week 10-Last Observation Carried Forward (LOCF)

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    End point title
    		 Mean Change From Baseline in V-Scale Composite Score (Sum of 9 Sub-Domains) of Vineland Adaptive Behavior Scales Second Edition-Parent Caregiver Rating Form (VABS-II/PCRF) at Week 10-Last Observation Carried Forward (LOCF) [1]
    End point description
    VABS-II/PCRF instrument:assess 3 domains(each with 3 subdomains):communication(subdomains:receptive,expressiveand writing), daily living skills(subdomains:personal,domestic,community), and socialization(subdomains:interpersonal relationships, play/leisure time, coping skills).Raw scores(2=always present, 1=sometimes present, 0=seldom or never present)rated by parent/caregiver from each subdomain were converted to standardized scores called V-scores. Each subdomain v-scale score ranged from 1(weakness)to 24(strength). V scores for 9 subdomains were summed to obtain composite V-score ranging from 9 to 216. Higher scores indicate higher level of adaptive functioning. ITT population: all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline assessment for at least 1 efficacy variable irrespective of compliance and protocol violations. Here “Number of Subjects Analyzed” signifies subjects who were evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Week 10
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data were planned to be analyzed for this endpoint.
    End point values
    		 Donepezil HCl Placebo
    Number of subjects analysed
    61
    65
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    83.1 ( 15.5 )
    85.7 ( 15.8 )
        Mean change from baseline at Week 10
    4.74 ( 9.2 )
    4.22 ( 8.5 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in V-Scale Composite Score (Sum of 9 Sub-domains) of Vineland Adaptive Behavior Scales Second Edition-Parent Caregiver Rating Form (VABS-II/PCRF) at Week 4 and 10-Observed Cases (OC)

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    End point title
    		 Mean Change From Baseline in V-Scale Composite Score (Sum of 9 Sub-domains) of Vineland Adaptive Behavior Scales Second Edition-Parent Caregiver Rating Form (VABS-II/PCRF) at Week 4 and 10-Observed Cases (OC)
    End point description
    VABS-II/PCRF instrument:assess 3 domains(each with 3 subdomains):communication(subdomains:receptive, expressive, and writing),daily living skills(subdomains:personal,domestic, community),and socialization(subdomains:interpersonal relationships,play/leisure time, coping skills).Raw scores(2=always present,1=sometimes present,0=seldom or never present)rated by parent/caregiver from each subdomain were converted to standardized scores called V-scores.Each subdomain v-scale score ranged as 1(weakness)to 24(strength).V scores for 9 subdomains were summed to obtain composite V-score as 9 to 216.Higher scores indicate higher level of adaptive functioning.ITT population:all randomized subjects who received 1 dose of drug and had at least 1 postbaseline assessment for 1 efficacy variable irrespective of compliance and protocol violations.Number of subjects analysed:subjects who were evaluable for this outcome measure.n:subjects who were evaluable for this outcome measure at given time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4 and Week 10
    End point values
    		 Donepezil HCl Placebo
    Number of subjects analysed
    61
    65
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    83.1 ( 15.5 )
    85.7 ( 15.8 )
        Mean change from baseline at Week 4 (n=54, n=60)
    1.5 ( 6.4 )
    2.6 ( 8.5 )
        Mean change from baseline at Week 10 (n=55, n=63)
    5.1 ( 9.6 )
    4.2 ( 8.6 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Test of Verbal Expression and Reasoning (TOVER) Total Score at Week 4 and 10-OC

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    End point title
    		 Mean Change From Baseline in Test of Verbal Expression and Reasoning (TOVER) Total Score at Week 4 and 10-OC
    End point description
    TOVER:subject performance based measure of expressive language function and verbal reasoning in response to questions about series of stylized pictures showing identifiable scenarios.64-item test was specifically designed to assess language function in children and adults with down syndrome(DS)across a broad range of functional ability. The test used 23 multi-colored pictures to stimulate verbal responses to questions.The test was short(completed in 15 minutes)and fast-paced(2 to 4 questions per picture). Total score ranging from 0 to 64, was derived from 64 questions, where higher score indicates better functional ability.ITT population:all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline assessment for at least 1 efficacy variable irrespective of compliance and protocol violations.Number of subjects analysed:subjects who were evaluable for this outcome measure.n:subjects who were evaluable for this outcome measure at given time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4 and Week 10
    End point values
    		 Donepezil HCl Placebo
    Number of subjects analysed
    62
    64
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    20.7 ( 12.2 )
    21.6 ( 11.4 )
        Mean change from baseline at week 4 (n=56, n=59)
    1.2 ( 6.4 )
    0.9 ( 8.5 )
        Mean change from baseline at week 10 (n=56, n=62)
    2.6 ( 6.2 )
    1.9 ( 5.5 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Test of Verbal Expression and Reasoning (TOVER) Total Score at Week 10-LOCF

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    End point title
    		 Mean Change From Baseline in Test of Verbal Expression and Reasoning (TOVER) Total Score at Week 10-LOCF
    End point description
    TOVER: subject-performance-based measure of expressive language function and verbal reasoning in response to questions about series of stylized pictures showing identifiable scenarios. 64-item test was specifically designed to assess language function in children and adults with down syndrome (DS) across a broad range of functional ability. The test used 23 multi-colored pictures to stimulate verbal responses to questions. The test was short (completed in 15 minutes) and fast-paced (2 to 4 questions per picture). Total score ranging from 0 to 64, was derived from 64 questions, where higher score indicates better functional ability. ITT population: all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline assessment for at least 1 efficacy variable irrespective of compliance and protocol violations. Here "Number of subjects analysed" signifies subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 10
    End point values
    		 Donepezil HCl Placebo
    Number of subjects analysed
    62
    64
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    20.7 ( 12.2 )
    21.6 ( 11.4 )
        Mean change from baseline at week 10
    2.4 ( 6.0 )
    2.1 ( 5.5 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 10 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    v11.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Liquid formulation matched to active treatment for oral administration.

    Reporting group title
    Donepezil HCl
    Reporting group description
    		 Blinded donepezil HCl 2.5 mg/day (2.5 mL/day) orally for subjects with BW 20 and <25 kg, 5 mg/day (5 mL/ day) orally for subjects with BW 25 to <50 kg, and 10 mg/day (10 mL/day) orally for subjects with BW >=50 kg liquid formulation (1 mg/1 mL) (titrated to 0.1 to 0.2 mg/kg/day based on BW).

    Serious adverse events
    		 Placebo Donepezil HCl
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Donepezil HCl
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 65 (64.62%)
    45 / 64 (70.31%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 65 (3.08%)
    5 / 64 (7.81%)
         occurrences all number
    2
    7
    Lethargy
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    Somnolence
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 65 (3.08%)
    1 / 64 (1.56%)
         occurrences all number
    2
    1
    Pyrexia
         subjects affected / exposed
    2 / 65 (3.08%)
    2 / 64 (3.13%)
         occurrences all number
    2
    2
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 65 (1.54%)
    2 / 64 (3.13%)
         occurrences all number
    1
    2
    Constipation
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 64 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    10 / 65 (15.38%)
    11 / 64 (17.19%)
         occurrences all number
    15
    17
    Nausea
         subjects affected / exposed
    2 / 65 (3.08%)
    5 / 64 (7.81%)
         occurrences all number
    2
    5
    Vomiting
         subjects affected / exposed
    2 / 65 (3.08%)
    8 / 64 (12.50%)
         occurrences all number
    2
    8
    incontinence faecal
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 65 (1.54%)
    4 / 64 (6.25%)
         occurrences all number
    1
    4
    Nasal congestion
         subjects affected / exposed
    2 / 65 (3.08%)
    1 / 64 (1.56%)
         occurrences all number
    2
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 65 (3.08%)
    3 / 64 (4.69%)
         occurrences all number
    2
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 64 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    Ear infection
         subjects affected / exposed
    3 / 65 (4.62%)
    1 / 64 (1.56%)
         occurrences all number
    4
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 64 (0.00%)
         occurrences all number
    2
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 65 (1.54%)
    2 / 64 (3.13%)
         occurrences all number
    1
    2
    Nasopharyngitis
         subjects affected / exposed
    4 / 65 (6.15%)
    0 / 64 (0.00%)
         occurrences all number
    6
    0
    Pharyngitis
         subjects affected / exposed
    1 / 65 (1.54%)
    3 / 64 (4.69%)
         occurrences all number
    1
    3
    Sinusitis
         subjects affected / exposed
    3 / 65 (4.62%)
    1 / 64 (1.56%)
         occurrences all number
    4
    1
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 65 (7.69%)
    6 / 64 (9.38%)
         occurrences all number
    5
    6
    Viral infection
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 65 (4.62%)
    1 / 64 (1.56%)
         occurrences all number
    3
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Mar 2008
    Protocol amendment 01: 1. New pregnancy reporting language was added to the AE section. Rationale: Eisai and Pfizer SOPs. 2. Concomitant medication list was changed to reflect Section 9.7 of the protocol, which allows stable use of psychotropic medications that are not highly anticholinergic and to allow as needed (PRN) use of additional medications to reflect current medical practice (Protocol Amendment II). Rationale: Administrative change to make concomitant medication list consistent with the protocol and current medical practice.

    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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