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    Summary
    EudraCT Number:2013-002523-42
    Sponsor's Protocol Code Number:D3250C00020
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-002523-42
    A.3Full title of the trial
    A multicenter, randomized, double-blind, parallel group, placebo-controlled, Phase 3 efficacy and safety study of benralizumab (MEDI-563) to reduce oral corticosteroid use in patients with uncontrolled asthma on high dose inhaled corticosteroid plus long acting beta2 agonist and chronic oral corticosteroid therapy (ZONDA)
    Ensayo en Fase 3, multicéntrico, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo, para evaluar la eficacia y la seguridad de Benralizumab (MEDI-563) para reducir el uso de corticosteroides orales en pacientes con asma no controlada, que están en tratamiento con dosis elevadas de corticosteroides inhalados, en combinación con un agonista beta-2 de acción larga y tratamiento crónico con corticosteroides orales (ZONDA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety study of Benralizumab to reduce OCS use in patients with uncontrolled asthma on high dose inhaled corticosteroid plus LABA and chronic OCS therapy
    Eficacia y la seguridad de Benralizumab para reducir el uso de corticosteroides orales en pacientes con asma no controlada, que están en tratamiento con dosis elevadas de corticosteroides inhalados, en combinación con un agonista beta-2 de acción larga y tratamiento crónico con corticosteroides orales
    A.3.2Name or abbreviated title of the trial where available
    ZONDA
    ZONDA
    A.4.1Sponsor's protocol code numberD3250C00020
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02075255
    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 SponsorAstraZeneca AB
    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 Farmacéutica Spain
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56, Parque Norte, Edificio Roble
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number0034900200444
    B.5.6E-mailinformacionEECC-Spain@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 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 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
    Asthma
    Asma
    E.1.1.1Medical condition in easily understood language
    Asthma (an illness that causes breathing difficulty) that is not fully controlled, so that episodes of breathing difficulty are still occuring despite the use of other available treatments
    Asma (enfermedad que causa dificultad para respirar) que no está completamente controlada,de modo que siguen ocurriendo episodios de dificultad para respirar a pesar del uso de otros ttos disponibles.
    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
    The effect of 2 dosing regimens of benralizumab on percentage reduction of Oral Corticosteroid dose in the terms of percentage reduction in final Oral Corticosteroid dose
    compared with week 0, while maintaining asthma control
    Comparar el efecto de dos pautas posológicas de benralizumab sobre la reducción porcentual de la dosis de OCS en terminos de reducción porcentual de la dosis final de OCS en comparación con la semana 0, mientras se mantiene el control del asma.
    E.2.2Secondary objectives of the trial
    To assess the effect of 2 dosing regimens of benralizumab on:
    -OCS dose in adult patients with uncontrolled asthma
    -parameters associated with asthma exacerbations
    -pulmonary function
    -asthma symptoms and other asthma control metrics
    Evaluar el efecto de dos pautas posológicas de benralizumab sobre:
    - la dosis de OCS en pacientes adultos con asma no controlado
    - los parámetros asociados a las reagudizaciones del asma
    - la función pulmonar
    - los síntomas del asma y otros indicadores del control del asma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Provision of informed consent prior to any study specific procedures
    2. Female and male aged from 18 to 75 years, inclusively
    3. History of physician-diagnosed asthma requiring treatment with medium dose ICS and a
    LABA
    4. Elevated level of peripheral blood eosinophil
    5. Documented treatment with high-dose ICS and LABA for at least 6 months prior to Visit 1
    6. Chronic oral prednisone or prednisolone therapy for at least 6 continuous months
    directly preceding Visit 1, and on a stable dose for at least one month prior to Visit 1
    7.Patients with documented failures of OCS reduction within 6 months prior to Visit 1 will not be required to proceed through the dose optimization phase during run-in.
    8. Morning pre-bronchodilator (Pre-BD) FEV1 of <80% predicted
    9. Either documented post bronchodilator (post-BD) reversibility of > o = 12% and > o = 200 mL in FEV1 or PC20 FEV1
    10. At least 1 documented asthma exacerbation in the previous 12 months prior to the date informed consent is obtained
    11. Optimized OCS dose reached at least 2 weeks prior to randomization
    12. Additional asthma controller medication must not have been initiated during run-in
    period
    13. At least 70% compliance with OCS use
    14. At least 70% compliance with usual asthma controller ICS-LABA
    15. Minimum 70% (i.e. 10 of 14 days) compliance with asthma daily diary (morning
    and evening diary)
    16. No documented asthma exacerbations during the screening/dose optimization period
    1. Otorgar el consentimiento informado con anterioridad a la realización de cualquiera de los procedimientos específicos del ensayo.
    2. Mujeres y varones de 18 a 75 años, ambos inclusive.
    3. Antecedentes de asma diagnosticado por un médico que requiere tratamiento con una dosis de intermedia de ICS y un LABA.
    4. Nivel elevado de eosinófilos en sangre periféricos.
    5. Tratamiento documentado con una dosis alta de ICS y un LABA, durante al menos 6 meses antes de la visita 1.
    6. Tratamiento crónico con prednisona o prednisolona oral durante al menos 6 meses de forma continuada justo antes de la visita 1 y recibiendo una dosis estable durante al menos un mes antes de la visita 1.
    7. Los pacientes con respuesta negativa a la reducción de OCS documentada en los 6 meses previos a la visita 1 no será necesario que pasen a la fase de optimización de la dosis durante la preinclusión.
    8. FEV1 matutino antes del broncodilatador (Pre-BD) <80% del valor teórico.
    9. Reversibilidad documentada del FEV1 después del broncodilatador (post-BD) > o = 12% y > o = 200 ml o concentración de metacolina que provoque una caída del FEV1 del 20% (PC20).
    10. Al menos 1 reagudización del asma documentada en los 12 meses anteriores a la fecha de obtención del consentimiento informado
    11. Obtener dosis optimizada de OCS al menos 2 semanas antes de la aleatorización.
    12. No se debe haber iniciado tratamiento con otros medicamentos controladores del asma durante el período de preinclusión.
    13. Al menos un 70% de cumplimiento del uso de OCS.
    14. Al menos un 70% de cumplimiento del tratamiento con el controlador del asma habitual de ICS-LABA.
    15. Cumplimiento mínimo del 70% (es decir, 10 de 14 días) del registro en el diario del asma (diario matutino y vespertino).
    16. Ninguna reagudización del asma documentada durante el período de selección/optimización de la dosis.
    E.4Principal exclusion criteria
    1. Clinically important pulmonary disease other than asthma or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts.
    2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological,musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
    - Affect the safety of the patient throughout the study
    - Influence the findings of the studies or their interpretations
    - Impede the patient?s ability to complete the entire duration of study
    3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
    4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in
    the study, or may influence the results of the study, or the patient?s ability to complete entire duration of the study
    5. History of life-threatening asthma
    6. Asthma control reached at an OCS dose of < o = 5mg during
    run-in/OCS optimization phase
    7. Qualifies for 3 consecutive dose reductions at Visits 2-4 and continues to meet OCS dose reduction criteria at Visit 5
    8. Receipt of oral dexamethasone as the maintenance oral steroid controller for asthma symptoms
    1. Otra enfermedad pulmonar clínicamente importante aparte del asma o haber sido diagnosticado alguna vez de una enfermedad pulmonar o sistémica, aparte del asma, que se asocie a recuentos elevados de eosinófilos.
    2. Cualquier trastorno, como por ejemplo cardiovascular, gastrointestinal, hepático, renal, neurológico, musculoesquelético, infeccioso, endocrino, metabólico, hematológico o psiquiátrico, o deterioro físico importante que no se encuentre estable en la opinión del investigador y que pudiera:
    - Afectar a la seguridad del paciente durante el ensayo.
    - Influir en los resultados de los estudios o en su interpretación.
    - Impedir que el paciente pueda completar toda la duración del ensayo.
    3. Infecciones agudas de las vías respiratorias altas o bajas que haya precisado antibióticos o antivirales en los 30 días anteriores a la fecha de obtención del consentimiento informado o durante el período de preinclusión/optimización.
    4. Cualquier resultado anómalo clínicamente significativo en la exploración física, constantes vitales, hematología, bioquímica o análisis de orina durante el período de preinclusión/optimización que, en opinión del investigador, pudiera suponer un riesgo para el paciente debido a su participación en el ensayo o influir en los resultados del ensayo o en la capacidad del paciente para completar toda la duración del ensayo.
    5. Antecedentes de asma potencialmente mortal.
    6. Alcanzar un control del asma con una dosis de OCS < o = 5 mg durante la fase de preinclusión/optimización de OCS .
    7. Cumplir los criterios para 3 reducciones consecutivas de la dosis en las visitas 2-4 y seguir cumpliendo los criterios de reducción de la dosis de OCS en la visita 5.
    8. Haber recibido dexametasona oral como controlador esteroide oral de mantenimiento para los síntomas del asma.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage reduction in final OCS dose compared with baseline (Visit 6), while maintaining asthma control
    Reducción porcentual de la dosis de OCS final comparado con el valor basal (visita 6), manteniendo el control del asma.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 28
    Semana 28
    E.5.2Secondary end point(s)
    The effect of 2 dosing regimens of benralizumab on:
    -OCS dose in terms of proportion of patients with > o = 50% reduction in average daily OCS dose at week 28 compared with dose at week 0 while maintaining asthma control average final OCS dose < o = 5.0 mg daily at week 28, while maintaining asthma control.
    -OCS dose in terms of proportion of patients with < o = 5.0 mg reduction on daily OCS dose at week 28 compared with dose at week 0, while maintaining asthma control.
    -Proportion of patients with > o = 1 asthma exacerbation after randomization, time to the first
    asthma exacerbation after randomization and annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization after randomization
    -pulmonary function in terms of change from week 0 in prebronchodilator Forced Expiratory Volume in 1 second (FEV1) and in prebronchodilator Inspiratory Capacity (IC), Expiratory Reserve Volume (ERV) and Inspiratory Reserve Volume (IRV).
    -asthma symptoms and other asthma control metrics in the terms of change from week 0 in asthma symptom score (total, daytime, and night time) and in rescue medication use.
    -asthma symptoms and other asthma control metrics in the terms of change from week 0 in the number of nights with awakening due to asthma requiring rescue medication.
    - asthma symptoms and other asthma control metrics in the terms of change from week 0 in Asthma Control Questionnaire 6 (ACQ-6).
    -asthma related health related quality of life in the terms of change from week 0 in Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12).
    -The pharmacokinetics (PK) of 2 dosing regimens of benralizumab in the terms of PK parameters
    -The immunogenicity of 2 dosing regimens of benralizumab in the terms of
    Anti-drug antibodies (ADA) presence or absence
    -The safety and tolerability of 2 dosing regimens of benralizumab in terms of Adverse Event (AE)/Serious Adverse Event (SAE)
    -The safety and tolerability of 2 dosing regimens of benralizumab in terms of laboratory variables
    -The safety and tolerability of 2 dosing regimens of benralizumab in terms of electrocardiogram (ECG) evaluation
    -The safety and tolerability of 2 dosing regimens of benralizumab in terms of physical examination results
    -The impact of 2 dosing regimens of benralizumab on blood eosinophil count.
    - The impact of 2 dosing regimens of benralizumab on biomarkers (subset of patients) in terms of quantification of sputum cytokines and biomarkers
    Efecto de dos pautas posológicas de benralizumab sobre:
    - la dosis de OCS en términos del porcentaje de pacientes con > o = 50% de reducción de la dosis media diaria de OCS en la semana 28 comparado con la dosis en la semana 0, manteniendo el control del asma.
    - la dosis de OCS en terminos del porcentaje pacientes con dosis media final de OCS < o = 5,0 mg diaria en la semana 28, manteniendo el control del asma.
    - la dosis de OCS en términos del porcentaje de pacientes con < o = 5,0 mg de reducción en la dosis diaria de OCS en la semana 28 comparado con la dosis basal en la semana 0, manteniendo el control del asma.
    - Porcentaje de pacientes con > o = 1 reagudización del asma después de la aleatorización, tiempo hasta la primera reagudización del asma después de la aleatorización y tasa anual de reagudizaciones del asma que está asociada a una visita a urgencias o a una hospitalización después de la aleatorización.
    - Función pulmonar en términos de cambio desde la semana 0 en el FEV1 pre-broncodilatador y en la capacidad inspiratoria (CI) pre-broncodilatador, volumen expiratorio de reserva (ERV) y volumen inspiratorio de reserva (IRV).
    - Síntomas del asma y otros indicadores del control del asma en términos de cambio desde la semana 0 en la puntuación de los síntomas del asma (total, diurna y nocturna) y en el uso de la medicación de rescate.
    - Síntomas del asma y otros indicadores del control del asma en términos de cambio desde la semana 0 en el Cuestionario de control del asma (ACQ-6).
    - Calidad de vida relacionada con la salud asociada al asma en términos de cambio desde la semana 0 en el Cuestionario normalizado de calidad de vida para pacientes con asma de 12 años en adelante (AQLQ(S)+12).
    - La farmacocinética (FC) de dos pautas posológicas de benralizumab en términos de parametros FC.
    - La inmunogenicidad de dos pautas posológicas de benralizumab en términos de la presencia o ausencia de anticuerpos contra el fármaco (ACF).
    - La seguridad y la tolerabilidad de dos pautas posológicas de benralizumab en términos de Acontecimientos adversos (AA)/Acontecimientos adversos graves (AAG).
    - La seguridad y la tolerabilidad de dos pautas posológicas de benralizumab en términos de variables de laboratorio.
    - La seguridad y la tolerabilidad de dos pautas posológicas de benralizumab en términos de evaluación del electrocardiograma (ECG).
    - La seguridad y la tolerabilidad de dos pautas posológicas de benralizumab en términos de los resultados de la exploración física.
    - el impacto de dos pautas posológicas de benralizumab sobre los niveles de eosinófilos en sangre.
    - Evaluar el impacto de dos pautas posológicas de benralizumab sobre biomarcadores (subgrupo de pacientes) en términos de cuantificación de citocinas en esputo y biomarcadores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 28
    Semana 28
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Argentina
    Canada
    Chile
    France
    Germany
    Poland
    United States
    E.8.7Trial has a data monitoring committee No
    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 (última visita último paciente)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 120
    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)
    Subjects will be offered participation in separate safety extension study
    A los pacientes se les ofrecerá la participación en un ensayo de extensión de seguridad separado
    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 Decision2015-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-06
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