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    Summary
    EudraCT Number:2018-001405-87
    Sponsor's Protocol Code Number:GLPG1690-CL-303
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-01-18
    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 number2018-001405-87
    A.3Full title of the trial
    A Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis.
    Ensayo multicéntrico de fase III aleatorizado, doble ciego, de grupos paralelos y controlado por placebo para evaluar la eficacia y la seguridad de 2 dosis de GLPG1690 en adición al tratamiento habitual durante al menos 52 semanas en sujetos con fibrosis pulmonar idiopática
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatment
    Estudio clínico para evaluar la eficacia y la seguridad de GLPG1690 en sujetos con fibrosis pulmonar idiopática (FPI) al utilizarlo junto con el tratamiento médico habitual
    A.4.1Sponsor's protocol code numberGLPG1690-CL-303
    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 SponsorGalapagos NV
    B.1.3.4CountryBelgium
    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 supportGalapagos NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalapagos NV
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressGeneraal De Wittelaan L11 A3
    B.5.3.2Town/ cityMechelen
    B.5.3.3Post code2800
    B.5.3.4CountryBelgium
    B.5.4Telephone number+34900 834 223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/088/16
    D.3 Description of the IMP
    D.3.1Product nameGLPG1690
    D.3.2Product code G451990
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNNot applicable
    D.3.9.2Current sponsor codeG451990
    D.3.9.3Other descriptive nameGLPG1690
    D.3.9.4EV Substance CodeSUB166266
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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 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 Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/088/16
    D.3 Description of the IMP
    D.3.1Product nameGLPG1690
    D.3.2Product code G451990
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNNot applicable
    D.3.9.2Current sponsor codeG451990
    D.3.9.3Other descriptive nameGLPG1690
    D.3.9.4EV Substance CodeSUB166266
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopatic pulmonary fibrosis
    Fibrosis pulmonar idiopática
    E.1.1.1Medical condition in easily understood language
    Idiopatic pulmonary fibrosis
    Fibrosis pulmonar idiopática
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10038738
    E.1.2Term Respiratory, thoracic and mediastinal disorders
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with IPF as evaluated by the rate of decline of FVC over a period of 52 weeks
    Evaluar la eficacia de dos dosis de GLPG1690 en adición al tratamiento habitual, en comparación con placebo, en sujetos con fibrosis pulmonar idiopática (FPI), determinada mediante el ritmo de descenso de la capacidad vital forzada (FVC) durante un período de 52 semanas.
    E.2.2Secondary objectives of the trial
    To evaluate the impact of two doses of GLPG1690 in addition to local standard of care compared to placebo in subjects with IPF on:
    - Disease progression defined as deterioration of FVC or all-cause mortality at 52 weeks
    - Respiratory-related hospitalization until the end of the study
    - Changes in quality of life (measured by St. George’s Respiratory Questionnaire [SGRQ] total score) at 52 weeks
    Evaluar el efecto de dos dosis de GLPG1690 en adición al tratamiento habitual, en comparación con placebo, en sujetos con FPI sobre:
    - Progresión de la enfermedad, definida como el deterioro de la FVC o la mortalidad por cualquier causa a las 52 semanas.
    - Hospitalización por causas respiratorias hasta el final del estudio.
    - Variaciones de la calidad de vida (medida mediante la puntuación total en el Cuestionario respiratorio del Hospital St. George [SGRQ]) a las 52 semanas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female subject aged >= 40 years on the day of signing the ICF.
    - A diagnosis of IPF within 5 years prior to the screening visit, as per applicable ATS/ERS/JRS/ALAT guidelines.
    - Chest HRCT historically performed within 12 months prior to the screening visit and according to the minimum requirements for IPF diagnosis by central review based on subject’s HRCT only (if no LB available), or based on both HRCT and LB (with application of the different criteria in either situation). If an evaluable HRCT <12 months prior to screening is not available, an HRCT can be performed at screening to determine eligibility, according to the same requirements as the historical HRCT.
    - Subjects receiving local standard of care for the treatment of IPF, defined as either pirfenidone or nintedanib, or neither pirfenidone nor nintedanib (for any reason).
    - The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan (investigator-determined).
    - Meeting all of the following criteria during the screening period: FVC >= 45% predicted of normal, Forced expiratory volume in 1 second (FEV1)/FVC >= 0.7, DLCO corrected for Hb >= 30% predicted of normal.
    - Estimated minimum life expectancy of at least 30 months for non IPF related disease in the opinion of the investigator.
    - Male subjects and female subjects of childbearing potential agree to use highly effective contraception/preventive exposure measures from the time of first dose of IMP (for the male subject) or the signing of the ICF (for the female subject), during the study, and until 90 days (male) or 30 days (female) after the last dose of IMP.
    - Able to walk at least 150 meters during the 6MWT at screening Visit 1; without having a contraindication to perform the 6MWT (see Appendix 10) or without a condition putting the subject at risk of falling during the test (investigator’s discretion). The use of a cane is allowed, the use of a stroller is not allowed at all for any condition. At Visit 2, for the oxygen titration test, resting SpO2 should be >= 88% with maximum 6 L O2/minute; during the walk, SpO2 should be >= 83% with 6 L O2/minute or >= 88% with <= L O2/minute.
    - Sujeto de cualquier sexo con una edad >= 40 años el día de la firma del documento de consentimiento informado.
    - Diagnóstico de FPI en los 5 años previos a la visita de selección, conforme a las directrices aplicables ATS/ERS/JRS/ALAT.
    - TCAR de tórax realizada en los 12 meses previos a la visita de selección y conforme a los requisitos mínimos para el diagnóstico de FPI, según una revisión centralizada basándose únicamente en la TCAR del sujeto (si no se dispone de BP) o en la TCAR y la BP (con aplicación de los diferentes criterios en cada situación). Cuando no se disponga de una TCAR evaluable en los 12 meses previos a la visita de selección, podrá realizarse una TCAR en el período de selección para determinar la elegibilidad, con arreglo a los mismos requisitos que la TCAR histórica.
    - Recepción activa del tratamiento habitual para la FPI, definido como pirfenidona o nintedanib o bien ni pirfenidona ni nintedanib (por cualquier motivo).
    - El grado de las alteraciones fibróticas es mayor que el grado de enfisema en la TCAR más reciente (determinada por el investigador).
    - Cumplimiento de todos los criterios siguientes durante el período de selección: FVC >= 45% del valor teórico de normalidad, Volumen espiratorio forzado en el primer segundo (FEV1)/FVC >= 0,7, DLCO corregida por Hb >= 30% del valor teórico de normalidad.
    - Esperanza de vida mínima estimada de 30 meses por enfermedades no relacionadas con la FPI, en opinión del investigador.
    - Varones y mujeres en edad fértil: deben comprometerse a utilizar métodos anticonceptivos/medidas de prevención de exposición muy eficaces desde la administración de la primera dosis del MEI (en los varones) o la firma del documento de consentimiento informado (en las mujeres), durante el estudio y hasta 90 días (varones) o 30 días (mujeres) después de la última dosis del MEI.
    - Capacidad de caminar al menos 150 metros durante la PM6M en la visita 1 de selección, sin ninguna contraindicación para realizar la PM6M y sin ningún proceso que suponga un riesgo de caída para el sujeto durante la prueba (a criterio del investigador). Se permite el uso de un bastón, pero se prohíbe terminantemente el uso de una silla de paseo por cualquier enfermedad. En la visita 2, para la prueba de ajuste de oxígeno, la SpO2 en reposo debe ser >= 88%, con un máximo de 6 l de O2/minuto; durante la prueba, la SpO2 debe ser >= 83% con 6 l de O2/minuto o >= 88% con <= l de O2/minuto.
    E.4Principal exclusion criteria
    - History of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin that has been treated with no evidence of recurrence, prostate cancer that has been medically managed through active surveillance or watchful waiting, squamous cell carcinoma of the skin if fully resected, and Ductal Carcinoma In Situ).
    - Acute IPF exacerbation within 6 months prior to screening and/or during the screening period.
    - Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period.
    - Interstitial lung disease associated with known primary diseases (e.g. sarcoidosis and amyloidosis), exposures (e.g. radiation, silica, asbestos, and coal dust), or drugs (e.g. amiodarone).
    - Diagnosis of severe pulmonary hypertension (investigator-determined).
    - Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to screening or during the screening period (e.g. acute coronary disease, heart failure, and stroke).
    - Underwent major surgery within 3 months prior to screening or have major surgery planned during the study period.
    - Abnormal LFT at screening, defined as AST, and/or ALT, and/or total bilirubin >= 1.5xULN, and/or GGT >= 3xULN. Retesting is allowed once.
    - Abnormal renal function defined as estimated creatinine clearance, calculated according to Cockcroft-Gault calculation (CCr) <30 mL/min. Retesting is allowed once.
    - Use of any of the following therapies within 4 weeks prior to screening and during the screening period, or planned during the study: warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil (except for occasional use), prednisone at steady dose >10 mg/day or equivalent.
    - Antecedentes de neoplasia maligna en los últimos 5 años (excepto carcinoma in situ de cuello uterino, carcinoma basocelular de piel tratado sin signos de recidiva, cáncer de próstata tratado médicamente mediante vigilancia activa o espera vigilante, carcinoma espinocelular de piel en caso de resección completa y carcinoma canalicular in situ).
    - Exacerbación aguda de la FPI en los 6 meses previos a la selección o durante el período de selección.
    - Infección de las vías respiratorias inferiores con necesidad de antibióticos en las 4 semanas previas a la selección o durante el período de selección.
    - Neumopatía intersticial asociada a enfermedades primarias conocidas (por ejemplo, sarcoidosis y amiloidosis), exposiciones (por ejemplo, radiación, sílice, amianto y polvo de carbón) o fármacos (por ejemplo, amiodarona).
    - Diagnóstico de hipertensión pulmonar grave (determinada por el investigador).
    - Enfermedad cardiovascular, pulmonar (distinta de la FPI) o de otro tipo inestable en los 6 meses previos a la selección o durante el período de selección (por ejemplo, enfermedad coronaria aguda, insuficiencia cardíaca o ictus).
    - Intervención de cirugía mayor en los 3 meses previos a la selección o previsión de una intervención de cirugía mayor durante el período del estudio.
    - Anomalías de las PFH en el período de selección, definidas como una concentración AST y/ó ALT y/ó bilirrubina total >= 1,5 veces el límite superior de la normalidad (LSN) y/ó GGT >= 3 veces el LSN. Se permite repetir la determinación una vez.
    - Función renal anormal, definida como un aclaramiento de creatinina estimado, calculado según la fórmula de Cockcroft-Gault (CCr) < 30 ml/min. Se permite repetir la determinación una vez.
    - Uso de cualquiera de los siguientes tratamientos en las 4 semanas previas a la selección y durante el período de selección o previsión de uso durante el estudio: warfarina, imatinib, ambrisentán, azatioprina, ciclofosfamida, ciclosporina A, bosentán, metotrexato, sildenafilo (excepto para uso ocasional) y prednisona en una dosis estable > 10 mg/día o equivalente.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of decline of FVC (in mL) over a period of 52 weeks
    Ritmo de descenso de la FVC (en ml) durante un período de 52 semanas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 52
    A la semana 52
    E.5.2Secondary end point(s)
    - Disease progression defined as the composite endpoint of first occurrence of ≥10% absolute decline in percent predicted forced vital capacity (%FVC) or all-cause mortality at 52 weeks
    - Time to first respiratory-related hospitalization until the end of the study
    - Change from baseline in the SGRQ total score at 52 weeks
    - Progresión de la enfermedad, definida como el criterio de valoración compuesto de un primer episodio de descenso absoluto ≥ 10% de la capacidad vital forzada teórica porcentual (%FVC) o la mortalidad por cualquier causa a las 52 semanas.
    - Tiempo transcurrido hasta la primera hospitalización por causas respiratorias hasta el final del estudio.
    - Variación de la puntuación total SGRQ entre el momento basal y la semana 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints during the trial as specified in the protocol
    Diferentes criterios de valoracion durante el estudio, tal y como se especifica en el protocolo.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Australia
    Belgium
    Chile
    Czech Republic
    Denmark
    Finland
    Germany
    Greece
    Peru
    Spain
    Taiwan
    Turkey
    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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 375
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 375
    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 state88
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 750
    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)
    None, subjects will revert to their standard of care.
    Ninguno, los sujetos volverán a su tratamiento habitual.
    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 Decision2018-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-02-10
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