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    Summary
    EudraCT Number:2015-002500-91
    Sponsor's Protocol Code Number:RPC01-3001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-002500-91
    A.3Full title of the trial
    A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
    Sperimentazione di estensione in aperto, multicentrica, di RPC1063 orale nella sclerosi multipla recidivante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
    Sperimentazione di estensione in aperto, multicentrica, di RPC1063 orale nella sclerosi multipla recidivante
    A.3.2Name or abbreviated title of the trial where available
    Open Label Extension (OLE) study
    Studio di estensione in aperto (OLE)
    A.4.1Sponsor's protocol code numberRPC01-3001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02576717
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    A.5.4Other Identifiers
    Name:NANumber:NA
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCELGENE INTERNATIONAL II SàRL
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene International II Sarl (CIS II)
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address86 Morris Avenue
    B.5.3.2Town/ cityNJ
    B.5.3.3Post code07901
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019137096862
    B.5.5Fax number00000000000
    B.5.6E-mailClinicalTrialDisclosure@celgene.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name0.25mg RPC1063
    D.3.2Product code RPC1063
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOzanimod HCL
    D.3.9.2Current sponsor codeRPC1063
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name1.0mg RPC1063
    D.3.2Product code RPC1063
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeOzanimod HCL
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/mg megabecquerel(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing Multiple Sclerosis
    sclerosi multipla recidivante
    E.1.1.1Medical condition in easily understood language
    Relapsing Multiple Sclerosis
    sclerosi multipla recidivante
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10048393
    E.1.2Term Multiple sclerosis relapse
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the long-term safety and tolerability of RPC1063 in patients with relapsing multiple sclerosis.
    Caratterizzare la sicurezza e la tollerabilit¿ a lungo termine di RPC1063 in pazienti affetti da sclerosi multipla recidivante.
    E.2.2Secondary objectives of the trial
    To characterize the long-term efficacy of RPC1063 in patients with relapsing multiple sclerosis.
    Caratterizzare l'efficacia a lungo termine di RPC1063 in pazienti affetti da sclerosi multipla recidivante.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in this trial, patients must meet all of the
    following criteria:
    1. Completed one of the parent trials
    2. Does not have a condition that would require withdrawal from one of the parent trials
    3. Has no conditions requiring treatment with a prohibited concomitant medication
    4. Is not receiving treatment with any of the following drugs or interventions within the corresponding timeframe: At Baseline (Day 1) CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg,
    rifampicin) Two weeks prior to Baseline (Day 1) Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
    5. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
    6. Female patients of childbearing potential: Must agree to practice a highly effective method of contraception
    throughout the study until completion of the 90-day Safety Follow-Up Visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.
    Acceptable methods of birth control in this study are the following:
    -Combined hormonal (oestrogen and progestogen containing)
    contraception, which may be oral, intravaginal, or transdermal
    -Progestogen-only hormonal contraception associated with inhibition of
    ovulation, which may be oral, injectable, or implantable
    -Placement of an intrauterine device (IUD)
    -Placement of an intrauterine hormone-releasing system (IUS)
    -Bilateral tubal occlusion
    -Vasectomised partner
    -Sexual abstinence

    All patients: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method (LAM) are not acceptable methods of contraception. Female condom and male condom should not be used together.
    Per essere eleggibili alla partecipazione a questo studio, i pazienti devono soddisfare i criteri seguenti:
    1.Aver completato una delle sperimentazioni primarie
    2.Non presentare patologie che richiederebbero il ritiro da una delle sperimentazioni primarie
    3.Non presentare patologie che richiedono il trattamento con un farmaco concomitante vietato
    4.Non riceve trattamento con uno qualsiasi dei seguenti farmaci o interventi all’
    interno dell’intervallo di tempo corrispondente:
    Alla baseline (Giorno 1)
    Inibitori (ad es. gemfibrozil o clopidogrel) o induttori (ad es. rifampicina) del
    CYP2C8
    Due settimane prima della baseline (Giorno 1)
    Inibitori della monoamino-ossidasi (ad es. selegilina, fenelzina)
    5.Capacità di fornire un consenso informato scritto e di attenersi alla programmazione delle valutazioni del protocollo
    6.I Pazienti di sesso femminile in età fertile:
    Devono accettare di usare un metodo di contraccezione altamente efficace durante tutto lo studio fino al completamento della visita di follow-up di sicurezza a 90 giorni.
    I metodi di contraccezione altamente efficaci sono quelli che, quando utilizzati singolarmente o in combinazione, hanno un tasso di insuccesso calcolato in base all'indice di Pearl inferiore all'1% annuo quando vengono utilizzati in modo coerente e corretto.
    I metodi di contraccezione accettabili per questo studio sono i seguenti:
    - contraccettivo ormonale combinato (contenente estrogeni e progestinici) che può essere assunto per via orale, intravaginale o transdermica
    - contraccezione ormonale a base di solo progestinico associata a inibizione dell'ovulazione in forma orale, iniettabile o impiantabile
    - inserimento di un dispositivo intrauterino (IUD)
    - inserimento di un sistema intrauterino a rilascio di ormoni (IUS)
    - occlusione bilaterale delle tube
    - partner vasectomizzato
    - astinenza sessuale


    Tutti i pazienti:
    L'astinenza periodica (metodi del calendario, sintotermici, post-ovulatori), il coito interrotto, l'uso di soli spermicidi e il metodo dell'amenorrea da lattazione (LAM) non sono metodi di contraccezione accettabili. I preservativi maschile e femminile non dovranno essere utilizzati insieme.
    E.4Principal exclusion criteria
    Patients that have a condition that would require withdrawal from one of the parent trials (RPC01-201 or RPC01-301)
    Pazienti che presentano una patologia che richiederebbe il ritiro da una delle sperimentazioni primarie (RPC01-201 o RPC01-301)
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability will be characterized in this trial by the incidence, relationship, and type of adverse events, serious adverse events, and adverse events leading to withdrawal from the trial; the incidence, relationship, and type of laboratory abnormalities; vital signs; electrocardiogram results; and physical examination abnormalities.
    Suicidality (Columbia-Suicide Severity Rating Scale) will be assessed in the trial. In addition, descriptive characterization will be provided for adverse events of special interest including bradycardia and heart conduction abnormalities (electrocardiogram and vital signs), pulmonary effects (forced expiratory volume at 1 second, forced vital capacity, and diffusing capacity of the lung for carbon monoxide measurements), macular edema (optical coherence tomography), hepatic effects (liver function tests), serious or opportunistic infections, and malignancy (see
    Protocol Section 12.4.2 for the complete list of AESIs). In addition, dependence and withdrawal symptoms will be assessed in at least 80 evaluable patients who discontinue study drug using the
    following assessments: PWC-20, HADS, ESS , vital signs, and the C-SSRS. Changes from last on-study-drug assessment for each withdrawal scale(PWC-20, HADS, ESS, C-SSRS and vital signs) to post study drug Day 1,4, 7, 14, 21, and 90 will be summarized.
    Efficacy Endpoints
    - Annualized relapse rate
    - Time to first relapse
    - The number of new or enlarging hyperintense T2-weighted brain magnetic resonance imaging lesions at each visit
    - The number of gadolinium-enhanced brain magnetic resonance imaging lesions at each visit
    -Time to onset of disability progression as defined by a sustained worsening in Expanded Disability Status Scale of 1.0 points or more from baseline, confirmed after 3 months and after 6 months
    - Proportion of patients who are free of gadolinium-enhanced lesions at each visit
    - Proportion of patients who are free of new or enlarging T2 lesions at each visit
    - Percent change in normalized brain volume (atrophy) on brain magnetic resonance imaging scans from Baseline at each visit
    -Change in Multiple Sclerosis Functional Composite score from Baseline at each visit (including the Low-Contrast Letter Acuity Test measurement of visual function as a component)
    -Change in Multiple Sclerosis Quality of Life 54 score from Baseline at each visit
    -Changes in other magnetic resonance imaging variables including but not limited to, number and volume of gadolinium-enhanced T1 lesions, volume of T2 lesions, number of new or enlarging T2 lesions, volume of unenhancing T1 lesions, number of new unenhancing T1 lesions
    In questa sperimentazione, la sicurezza e la tollerabilità saranno caratterizzate in base a incidenza, correlazione e tipo di eventi avversi, eventi avversi seri ed eventi avversi che comportano il ritiro dalla sperimentazione; incidenza, correlazione e tipo di risultati anomali delle analisi di laboratorio; funzioni vitali; risultati dell'elettrocardiogramma; anomalie riscontrate all'esame obiettivo.
    Nella sperimentazione saranno valutate le tendenze suicide (Columbia-Suicide Severity Rating Scale). Inoltre, sarà fornita la caratterizzazione descrittiva degli eventi avversi di particolare interesse compresi bradicardia e anomalie della conduzione cardiaca (elettrocardiogramma e funzioni vitali), effetti polmonari (misurazioni di volume espiratorio forzato in 1 secondo, capacità vitale forzata e capacità di diffusione polmonare del monossido di carbonio), edema maculare (tomografia a coerenza ottica), effetti epatici (test di funzionalità epatica), infezioni gravi o opportunistiche e tumori maligni. (Vedere Protocollo Sezione 12.4.2 per l'elenco completo delle AESI)
    Inoltre, i sintomi di dipendenza e di astinenza saranno valutati in almeno 80 pazienti valutabili che interrompono il farmaco in studio utilizzando le seguenti valutazioni: PWC-20, HADS, ESS, segni vitali e C-SSRS. Cambiamenti dall'ultima valutazione del farmaco in studio per ciascuna scala di prelievo (PWC-20, HADS, ESS, C-SSRS e segni vitali) per pubblicare il farmaco Day 1,4, 7, 14, 21 e 90 saranno riassunti.


    Endpoint di efficacia
    - Tasso di recidiva annualizzato
    - Tempo fino alla prima recidiva
    - Numero di lesioni iperintense nuove o in espansione sulle immagini di risonanza magnetica cerebrale T2-pesate ad ogni visita
    - Numero di lesioni captanti il gadolinio sulle immagini di risonanza magnetica cerebrale ad ogni visita
    - Tempo all'insorgenza della progressione della disabilità definita da un peggioramento prolungato della Expanded Disability Status Scale di 1,0 o più punti, confermato dopo 3 mesi e dopo 6 mesi
    - Proporzione di pazienti che non presentano lesioni captanti il gadolinio a ogni visita
    - Proporzione di pazienti che non presentano lesioni T2 nuove o in espansione ad ogni visita
    - Variazione percentuale del volume cerebrale normalizzato (atrofia) sulle immagini di risonanza magnetica cerebrale dalla visita Basale ad ogni visita
    - Variazione del punteggio Multiple Sclerosis Functional Composite dalla visita Basale ad ogni visita pertinente (compresa la misura mediante test Low-Contrast Letter Acuity Test della funzione visiva quale componente)
    - Variazione del punteggio Multiple Sclerosis Quality of Life 54 dalla visita Basale a ogni visita pertinente
    - Variazioni di altre variabili della risonanza magnetica per immagini, compresi a titolo esemplificativo, numero e volume delle lesioni T1 captanti il
    gadolinio, volume delle lesioni T2, numero delle lesioni T2 nuove o in espansione, volume delle lesioni T1 non captanti, numero di nuove lesioni T1 non captanti
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 3 month visit,every 6 Month Visit for subjects who have completed their 3rd annual visit , follow-up visit and during the unscheduled relapse visit if applicable
    Visita ogni 3 mesi, ogni 6 mesi Visita per soggetti che hanno completato la loro terza visita annuale, visita di follow-up e durante la visita non programmata per recidiva se pertinente
    E.5.2Secondary end point(s)
    none
    nessuno
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA199
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belarus
    Bosnia and Herzegovina
    Georgia
    Mexico
    Moldova, Republic of
    New Zealand
    Russian Federation
    Serbia
    South Africa
    Ukraine
    United States
    Belgium
    Bulgaria
    Croatia
    Estonia
    Germany
    Greece
    Hungary
    Italy
    Latvia
    Lithuania
    Poland
    Portugal
    Romania
    Slovakia
    Spain
    Sweden
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2496
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2407
    F.4.2.2In the whole clinical trial 2496
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    All patients who are receiving clinical benefit from treatment with
    RPC1063 to continue to receive it until marketing authorization is
    obtained in their country, or until the Sponsor discontinues the
    development program.
    Tutti i pazienti che traggono beneficio clinico dal trattamento con RPC1063 continueranno a riceverlo fino all'ottenimento dell'autorizzazione all'immissione in commercio nel rispettivo Paese o fino a quando lo Sponsor interromperà il programma di sviluppo.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
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