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    Summary
    EudraCT Number:2013-004590-27
    Sponsor's Protocol Code Number:D3251C00003
    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:2014-06-03
    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 number2013-004590-27
    A.3Full title of the trial
    Randomised, double-blind, 56 week placebo-controlled, parallel group, multicentre, phase 3 study to evaluate the efficacy and safety of 2 doses of benralizumab in patients with moderate to very severe COPD with a history of exacerbations (GALATHEA)
    Studio clinico di fase III, multicentrico, randomizzato, a gruppi paralleli, in doppio cieco, a somministrazione cronica (56 settimane) controllato verso placebo, per valutare l’efficacia e la sicurezza di 2 dosi di benralizumab (MEDI-563) in pazienti con Broncopneumopatia Cronica Ostruttiva (BPCO) da moderata a molto grave con una storia di riacutizzazioni (GALATHEA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of 2 benralizumab doses in moderate to very severe COPD patients with prior exacerbation history
    Valutare l'efficacia e la sicurezza di due dosi di benralizumab sulle riacutizzazioni di BPCO in soggetti con BPCO da moderata a molto grave.
    A.3.2Name or abbreviated title of the trial where available
    GALATHEA
    GALATHEA
    A.4.1Sponsor's protocol code numberD3251C00003
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/020/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressVastra Malarehamnen
    B.5.3.2Town/ citySodertalje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.6E-mailClinicalTrialTransparency@astrazeneca.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 namebenralizumab
    D.3.2Product code Medi-563
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbenralizumab
    D.3.9.1CAS number 1044511-01-4
    D.3.9.2Current sponsor codeMEDI-563
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 namebenralizumab
    D.3.2Product code Medi-563
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbenralizumab
    D.3.9.1CAS number 1044511-01-4
    D.3.9.2Current sponsor codeMEDI-563
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Obstructive Pulmonary Disease
    Broncopneumopatia Cronica Ostruttiva (BPCO)
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease that cause exacerbations which can no be fully controlled using standard care of treatment
    Broncopneumopatia Cronica Ostruttiva (BPCO) che causa riacutizzazioni che non possono essere completamente controllate usando i trattamenti standard.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of benralizumab on COPD exacerbations in subjects with moderate to very severe COPD
    Valutare l’effetto di benralizumab sulle riacutizzazioni di BPCO in soggetti con BPCO da moderata a molto grave.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of benralizumab:
    - on health status/health-related quality of life
    - on pulmonary function
    - on respiratory symptoms
    - on rescue medication use
    - on nocturnal awakenings
    - on the severity, frequency and duration of EXACT-PRO defined events
    - on healthcare resource utilization due to COPD
    - on general health status
    - on blood eosinophil levels
    To evaluate the pharmacokinetics parameters of benralizumab.
    Assessment of the safety and tolerability of benralizumab.
    To evaluate the immunogenicity of benralizumab
    Valutare l’effetto di benralizumab:
    - sullo stato di salute/qualità della vita correlata alla salute
    - sulla funzione polmonare
    - sui sintomi respiratori
    - sull’uso di farmaci salvavita
    - sui risvegli notturni
    - sulla gravità, frequenza e durata di eventi definiti EXACT-PRO
    - sull'utilizzo delle risorse di assistenza sanitaria dovuto alla BPCO
    - sullo stato generale di salute
    - sui livelli di eosinofili nel sangue
    - i parametri farmacocinetici e l’immunogenicità di benralizumab
    - Valutare la sicurezza e la tollerabilità di benralizumab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Additional pulmonary function tests:

    To evaluate the effect of two doses of
    benralizumab in a subset of patients for lung
    volumes.
    To evaluate the effect of two doses of
    benralizumab in a subset of patients for DLCO.
    To evaluate the effect of two doses of
    benralizumab in a subset of patients on exercise
    endurance.

    Sputum analysis:
    To evaluate the effect of two doses of
    benralizumab on sputum biomarkers/cell counts
    in a subset of patients.
    Ulteriori test di funzionalità polmonare:
    - Valutare l’effetto di due dosi di benralizumab su volumi polmonari in un sottogruppo di soggetti
    - Valutare l’effetto di due dosi di benralizumab su DLCO in un sottogruppo di soggetti
    - Valutare l’effetto di due dosi di benralizumab su un esercizio di resistenza in un sottogruppo di soggetti
    E.3Principal inclusion criteria
    1.Informed consent.
    2.Subjects 40-85 y.o.
    3.Moderate to very severe COPD with post-BD FEV1>20% and ≤65% .
    4.≥2 moderate or ≥1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1.
    5.mMRC score ≥1 at Visit 1.
    6.Treatment with double or triple therapy in the year prior to Visit 1, constant 2 weeks prior to Visit 1. 7.Tobacco history of ≥10 pack-years.
    8.Women of childbearing potential must use a highly effective form of birth control from Visit 1 until 16 weeks after their last dose, and negative serum pregnancy test result at Visit 1.
    9.Male subjects who are sexually active must be surgically sterile one year prior to Visit 1 or use an adequate method of contraception from the first IP dose until 16 weeks after their last dose. 10.Compliance with maintenance therapy during run-in ≥70%.
    1. consenso informato.
    2. età compresa tra 40-85 anni compiuti.
    3. BPCO da moderata a molto grave con FEV1/FVC post-broncodilatatore >20% e ≤65%.
    4. ≥ 2 riacutizzazioni moderate o ≥ 1 riacutizzazione grave della BPCO che hanno richiesto trattamento o ospedalizzazione nelle 2 -52 settimane precedenti la visita 1.
    5. punteggio mMRC ≥ 1 alla Visita 1.
    6. doppia o triplice terapia durante l'anno precedente Visita 1, stabile da almeno 2 settimane prima dellaVisita 1.
    7. storia di fumo ≥ 10 pacchetti-anno.
    8. Donne in età fertile devono usare una forma altamente efficace di controllo delle nascite da Visita 1 fino a 16 settimane dopo l' ultima dose, e test di gravidanza su siero negativo alla Visita 1.
    9. maschi che sono sessualmente attivi devono essere chirurgicamente sterili da almeno un anno prima della Visita 1 o devono usare un adeguato metodo contraccettivo dalla prima dose di IP fino a 16 settimane dopo l' ultima dose.
    10. L'aderenza al trattamento con la terapia di mantenimento durante il periodo di run in deve essere ≥70%.
    E.4Principal exclusion criteria
    1. Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
    2. Any disorder or major physical impairment that is not stable by Investigator opinion and could affect: - subject safety−study findings or their interpretation or subject’s ability to complete the entire study duration.
    3. Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator’s judgment may put the patient at risk or negatively affect the study outcome.
    4. Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to Visit1.
    5. Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 2 weeks prior to Visit1.
    6. Pneumonia within 8 weeks prior to Visit1.
    7. Pregnant, breastfeeding, or lactating women.
    8. Risk factors for pneumonia
    9. History of anaphylaxis to any other biologic therapy.
    10. Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure.
    11. Use of immunosuppressive medication within 28 days prior to randomisation.
    12. Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.
    13. Evidence of active tuberculosis (TB), either treated or untreated, or latent TB without an appropriate course of treatment.
    14. Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable).
    15. Asthma as a primary or main diagnosis according to the GINA guidelines or other accepted guidelines.
    16. Previous treatment with benralizumab.
    17. Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.
    1. Malattia polmonare clinicamente importante diversa da BPCO o altra malattia polmonare diagnosticata o sistemica che è associata con elevata conta degli eosinofili periferici.
    2. Qualsiasi disturbo o compromissione fisica maggiore che non è stabile a giudizio dello sperimentatore e potrebbe influenzare : -la sicurezza del soggetto durante lo studio; - i risultati dello studio o la loro interpretazione; - ostacolare la capacità del soggetto di completare lo studio.
    3. Cardiopatia ischemica instabile, aritmia, cardiomiopatia o qualsiasi altro disturbo cardiovascolare rilevante a giudizio dallo sperimentatore che può mettere il paziente a rischio o influenzare negativamente l'esito dello studio.
    4. Trattamento con corticosteroidi e/o antibiotici sistemici, e/o ospedalizzazione per riacutizzazione perBPCO entro 2 settimane prima di visita 1.
    5. Infezione acuta delle vie respiratorie superiori o inferiori che richieda antibiotici o farmaci antivirali nelle due settimane precedenti la Visita 1.
    6. Polmonite entro 8 settimane prima Visita 1.
    7. Gravidanza, allattamento, o donne che allattano
    8. Fattori di rischio per la polmonite
    9. Storia di anafilassi a qualsiasi altra terapia biologica
    10. Ossigenoterapia a lungo termine con segni e/o sintomi di cor pulmonale, insufficienza ventricolare destra
    11. Uso di farmaci immunosoppressori nei 28 giorni precedenti la randomizzazione
    12. Assunzione di qualsiasi prodotto sperimentale non biologico entro 30 giorni o 5 emivite prima della Visita 1
    13. evidenza di tubercolosi attiva (TB), sia trattata sia non trattata, o TB latente senza un trattamento in corso appropriato.
    14. riduzione chirurgica del volume polmonare nei sei mesi precedenti la Visita 1. Storia di parziale o totale resezione polmonare (singolo lobo o segmentectomia è accettabile).
    15. Asma come diagnosi primaria o principale, secondo le linee guida Global Initiative for Asthma (GINA) o altre linee guida accettate.
    16. Precedente trattamento con benralizumab.
    17. Infezione parassitaria da elminti diagnosticata nelle 24 settimane precedenti la Visita 1.
    E.5 End points
    E.5.1Primary end point(s)
    Annual COPD exacerbation rate
    Tasso Annuale di riacutizzazioni della BPCO
    E.5.1.1Timepoint(s) of evaluation of this end point
    56 week
    56 settimane
    E.5.2Secondary end point(s)
    - SGRQ (St. George’s Respiratory Questionnaire)
    -CAT (Chronic Obstructive Pulmonary Disease assessment tool)
    - Pre-dose/pre-bronchodilator FEV1 at the study center
    - BDI/TDI (Baseline/Transitional Dyspnea Index)
    - Total rescue medication use (average puffs/day), recorded by patient using electronic diary
    - Number of nights with awakening due to COPD, recorded by patient using electronic diary.
    - EXACT-PRO (Exacerbations of Chronic Pulmonary Disease Tool – Patient-reported Outcome) questionnaire
    - COPD (Chronic Obstructive Pulmonary Disease) specific resource utilization (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other Chronic Obstructive Pulmonary Disease medications)
    - PK (pharmacokinetics) - steady-state serum pre-dose concentration
    - Adverse Events/ Serious Adverse Events (AE/SAE) - Laboratory variables - 12 lead ECG (Electrocardiogram) - Physical Examination - Vital Signs
    - Determination of Anti-drug antibodies (ADA)
    - EQ-5D-5L (European Quality of Life-5 Dimensions) questionnaire
    - Blood eosinophils levels
    - Questionario St. George’s Respiratory (SGRQ)*
    - COPD assessment tool (CAT), questionario di valutazione della BPCO
    - Volume espiratorio forzato in un secondo (FEV1) Pre-dose/ pre-broncodilatatore, al centro sperimentale
    - Indice di Dispnea Basale/Transizionale (BDI/TDI)
    - Uso totale di soccorso farmaci salvavita (media Puffs al giorno), registrati dal paziente usando il diario elettronico
    - Numero di notti con risvegli a causa della BPCO, registrati dal paziente usando il diario elettronico
    - Exacerbations of Chronic Pulmonary Disease Tool – Patient-reported Outcome (EXACT-PRO)
    - Utilizzo di specifiche risorse per BPCO (visite mediche non programmate, telefonate non programmate ai medici, uso di altri medicinali per la BPCO)
    - Parametri di farmacocinetica (PK) - andamento costante della concentrazione sierica pre-dosaggio
    - Eventi Avversi/ Eventi Avversi Serii (AE/SAE), Variabili di Laboratorio, Electrocardiogramma a 12 derivazioni (ECG), Esame fisico, Segni Vitali
    - determinazione di Anticorpi anti-farmaco (ADA)
    - questionario European Quality of Life-5 Dimensions (EQ-5D-5L)
    - livello di Eosinofili nel sangue
    E.5.2.1Timepoint(s) of evaluation of this end point
    maximum of 60 weeks
    massimo 60 settimane
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA150
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Canada
    Czech Republic
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Switzerland
    United Kingdom
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 872
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 871
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1172
    F.4.2.2In the whole clinical trial 1743
    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)
    Standard of care
    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 Decision2014-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
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