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    Summary
    EudraCT Number:2022-000152-11
    Sponsor's Protocol Code Number:D3250R00107
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-27
    Trial 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 number2022-000152-11
    A.3Full title of the trial
    BURAN: Effects of Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma using Functional Respiratory Imaging Parameters
    BURAN: Efecto del Benralizumab sobre la dinámica de la vía aérea en el asma eosinofílico severo utilizando parámetros respiratorios funcionales de diagnóstico por imagen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma using Functional Respiratory Imaging
    BURAN: Benralizumab sobre la dinámica de la vía aérea en el asma eosinofílico severo mediante diagnóstico por imagen respiratorio funcional
    A.3.2Name or abbreviated title of the trial where available
    BURAN
    BURAN
    A.4.1Sponsor's protocol code numberD3250R00107
    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
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concorde Pike
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1877240 9479
    B.5.6E-mailInformation.Center@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 Yes
    D.2.1.1.1Trade name FASENRA™
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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.3.9.3Other descriptive nameFASENRA , formerly MEDI-563
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    Asthma
    Asma
    E.1.1.1Medical condition in easily understood language
    Asthma is a disease that makes breathing difficult as there is swelling of the air passages resulting in airway narrowing. In severe eosinophilic asthma, this is caused by eosinophils blood cells.
    Asma es una enfermedad que dificulta la respiración,ya que hay inflamación de vías respiratorias que provoca su estrechamiento.En asma eosinofílica grave,la causa son lascélulas sanguíneas eosinófilas
    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 PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 describe the change from baseline in airway dynamics at week 13 following treatment with benralizumab, using siVaw (specific airway volume) measurements from trimmed airways.
    Evaluar el cambio frente al basal en la dinámica de la vía aérea en la semana 13 tras el tratamiento con benralizumab, utilizando las mediciones del siVaw (volumen específico de la vía aérea [specific airway volume]) de las vías aéreas “recortadas”.
    E.2.2Secondary objectives of the trial
    1. To describe the change from baseline in airway dynamics at week 13
    following treatment with benralizumab, as measured by FRI endpoints
    and mucus plugs scores, irrespective of patient characteristics.
    2. To describe the relationship between airway dynamics and
    conventional lung function measurements, cross-sectionally (at week 0)
    and irrespective of patient characteristics.
    3. To describe the relationship between changes from baseline (week 0)
    in airway dynamics and conventional lung function measurements at
    week 13, after accounting for baseline measurements of conventional
    lung function.
    1. Evaluar el cambio frente al basal en la dinámica de la vía aérea en la semana 13 tras el tratamiento con benralizumab, medida mediante los criterios de valoración FRI y las puntuaciones de los tapones mucosos, independientemente de las características del paciente.
    2. Evaluar la relación entre la dinámica de la vía aérea y las medidas convencionales de la función pulmonar, de manera transversal (en la semana 0) e independientemente de las características del paciente.
    3. Evaluar la relación entre los cambios frente al basal (semana 0) en la dinámica de la vía aérea y las medidas convencionales de la función pulmonar en la semana 13, considerando las mediciones basales convencionales de la función pulmonar.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participants who are diagnosed with asthma with documented reversibility post-bronchodilator or salbutamol either historical or at Visit 0 (V0).
    - Participants who have documented treatment with ICS and LABA for >= 3 months prior to V0 with or without oral corticosteroids and additional asthma controllers.
    - Participants who have documented peripheral blood eosinophil count >= 300 cells/μL at V0, or if Oral Corticosteroids (OCS)-dependent, a documented peripheral blood eosinophil count >= 150 cells/μL at V0.
    - Participants who have had a minimum of 2 exacerbations in the last 12 months prior to V0.
    - Participants who have pre-bronchodilator Forced Vital Capacity (FVC) < 65% of predicted at V0.
    - Participants who have pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% of predicted at V0.
    - Participants who have stable asthma regimen apart from the use of rescue medication including the use of any other asthma medication for at least 3 months prior to V0.
    - Participants who can perform acceptable and repeatable spirometry.
    - Participants who can withhold asthma maintenance medication for at least 12 hours prior to V0, 1 and 4 where spirometry and/or Computed Tomography (CT) scan procedures will be performed except for once-a-day dosage where 24 hours will be required.
    - Female participants who have a negative pregnancy test prior to administration of the investigational product (IP) and high-resolution CT scan and must agree to use a highly effective method of birth control from randomization throughout the study duration and within 12 weeks after last dose of IP.
    - Participantes diagnosticados de asma con reversibilidad documentada tras broncodilatador o salbutamol, ya sea histórica o en la Visita 0 (V0).
    - Participantes que hayan recibido tratamiento documentado con corticosteroides inhalados (inhaled corticosteroids, ICS) y agonistas Beta2 de acción prolongada (long-acting beta2-agonists, LABA) durante >= 3 meses antes de la V0, con o sin corticosteroides orales y otros medicamentos de control del asma.
    - Participantes con una cifra documentada de eosinófilos en sangre periférica >= 300 células/μL en la V0 o, en caso de dependencia de los corticosteroides orales (oral corticosteroids, OCS), una cifra documentada de eosinófilos en sangre periférica >= 150 células/μL en la V0.
    - Participantes que hayan tenido un mínimo de 2 exacerbaciones en los 12 meses anteriores a la V0.
    - Participantes con una capacidad vital forzada (forced vital capacity, FVC) antes del broncodilatador < 65% del valor teórico en la V0.
    - Participantes con un volumen espiratorio forzado en el primer segundo (forced expiratory volume in 1 second, FEV1) antes del broncodilatador < 80% del valor teórico en la V0.
    - Participantes con un régimen estable para el asma, aparte del uso de la medicación de rescate, lo que incluye el uso de cualquier otra medicación para el asma durante por lo menos 3 meses antes de la V0.
    - Participantes capaces de realizar una espirometría aceptable y repetible.
    - Participantes que puedan suspender la medicación de mantenimiento para el asma durante por lo menos 12 horas antes de la V0, la V1 y la V4 en las que se llevarán a cabo espirometrías y/o tomografías computarizadas (computed tomography, CT), excepto en el caso de administración una vez al día, en la que se precisarían 24 horas.
    - Mujeres participantes con una prueba de embarazo negativa antes de la administración del producto en investigación (investigational product, IP) y de la tomografía computarizada de alta resolución, y que acepten utilizar un método anticonceptivo muy efectivo desde la aleatorización, a lo largo del estudio y durante las 12 semanas siguientes a la última dosis del IP.
    E.4Principal exclusion criteria
    - Participants who are unstable or who developed an exacerbation/infection in the 6 weeks before V0.
    - Participants with acute upper or lower airway infection in the 6 weeks before V0.
    - Participants diagnosed with clinically important pulmonary disease other than asthma, or participants who have ever been diagnosed with pulmonary or systemic disease, other than asthma that are associated with elevated peripheral eosinophil count.
    - Receipt of any biologic products for asthma within 4 months or 5 half-lives prior to V0 whichever is longer.
    - Receipt of maintenance long-acting muscarinic antagonist (LAMA) containing products in combination or isolated 90 days prior to V0.
    - History or current use of chronic (i.e., > 4 weeks) immunosuppressive medication.
    - History of lung volume reduction surgery, lung resection, thermal bronchoplasty at any time before visit 0 (V0) or on active phase of pulmonary rehabilitation.
    - Participants with current malignancy or history of malignancy.
    - History of other clinically significant disease or abnormality.
    - Participants with positive Hepatitis B, C or HIV.
    - Participants with:
    Positive COVID-19 test at V0, COVID-19 disease within 6 weeks before V0 or History of severe COVID-19 disease at any time, defined by the need for Intensive Care Unit stay or Mechanical Ventilation (invasive or non-invasive).
    - Participantes en situación inestable o que hayan presentado una exacerbación/infección en las 6 semanas anteriores a la V0.
    - Participantes con infección aguda de las vías respiratorias superiores o inferiores en las 6 semanas anteriores a la V0.
    - Participantes diagnosticados de una enfermedad pulmonar clínicamente importante distinta del asma, o participantes a los que se les haya diagnosticado alguna vez una enfermedad pulmonar o sistémica, distinta del asma, acompañada de una cifra elevada de eosinófilos en sangre periférica.
    - Recepción de cualquier producto biológico para el asma en los 4 meses o 5 semividas anteriores a la V0, lo que sea más largo.
    - Recepción de tratamiento de mantenimiento con productos que contengan antagonistas muscarínicos de acción prolongada (long-acting muscarinic antagonists, LAMA) en combinación o aislados 90 días antes de la V0.
    - Tratamiento crónico (es decir, > 4 semanas) con inmunosupresores en el pasado o en la actualidad.
    - Antecedentes de cirugía de reducción del volumen pulmonar, resección pulmonar, broncoplastia térmica en cualquier momento antes de la V0 o en fase activa de rehabilitación pulmonar.
    - Participantes con neoplasia maligna actual o antecedentes de neoplasia maligna.
    - Antecedentes de otras enfermedades o anomalías clínicamente importantes.
    - Participantes con pruebas positivas de hepatitis B o C o del virus de la inmunodeficiencia humana (human immunodeficiency virus, HIV).
    - Participantes con:
    Prueba de COVID-19 positiva en la V0, enfermedad por coronavirus de 2019 (COVID-19) en las 6 semanas anteriores a la V0 o antecedentes de COVID-19 grave en cualquier momento, definida por la necesidad de estancia en la Unidad de Cuidados Intensivos o de ventilación mecánica (invasiva o no invasiva).
    E.5 End points
    E.5.1Primary end point(s)
    Unadjusted within subject difference in siVaw (specific airway volume) measured at TLC, calculated as the mean percent change from baseline (week 0) at week 13 (± 5 days).
    Diferencia intraindividual no ajustada en el siVaw (volumen específico de la vía aérea) medido a la TLC (capacidad pulmonar total [total lung capacity]), calculado como el cambio porcentual medio frente al basal (semana 0) en la semana 13 (± 5 días).
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline (week 0)
    week 13 (± 5 days)
    basal (semana 0)
    semana 13 (± 5 días)
    E.5.2Secondary end point(s)
    1. Unadjusted within subject difference in iVlung, iVlobe, iVaww, air trapping, iRaw, mucus plugs score, BVX, IAD, ventilation mapping and ventilation/perfusion mapping, comparing baseline (week 0) to week 13 (± 5 days).
    2. Correlation between imaging endpoints [FRI endpoints (siVaw, iVlung, iVlobe, iVaww, air trapping, iRaw, BVX, IAD, ventilation mapping and ventilation/perfusion mapping) and mucus plugs score] and pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1) at week 0.
    Correlation between imaging endpoints [FRI endpoints and mucus plugs score] and pre-bronchodilator forced vital capacity (pre-BD FVC) at week 0.
    Scatter plots of FRI endpoints and mucus plugs score versus conventional lung function measures (pre-BD FEV1 and pre-BD FVC) at week 0.
    Estimated increases in FRI endpoints and mucus plugs score for every one percent increase in pre-BD FEV1 and pre-BD FVC at week 0.
    3. Correlation between the change from week 0 in imaging endpoints [FRI endpoints and mucus plugs score] at week 13 and the change from week 0 in pre-BD FEV1 at week 13 (± 5 days), overall and within subgroups conditional on the baseline value of pre-BD FEV1.
    Correlation between the change from week 0 in imaging endpoints [FRI endpoints and mucus plugs score] at week 13 and the change from week 0 in pre-BD FVC at week 13 (± 5 days), overall and within subgroups conditional on the baseline value of pre-BD FVC.
    Scatter plots of changes from week 0 in FRI endpoints and mucus plugs score at week 13 vs. changes from week 0 in conventional lung function measures (pre-BD FEV1 and pre-BD FVC) at week 13.
    Estimated change over time (week 13 vs. week 0) in FRI endpoints and mucus plugs score, with and without adjustment for conventional lung function measures (pre-BD FEV1 and pre-BD FVC).
    1. Diferencia intraindividual no ajustada en iVlung, iVlobe, iVaww, atrapamiento aéreo, iRaw, puntuación de los tapones mucosos, BVX, IAD, mapeo de la ventilación y mapeo de la ventilación/perfusión, en comparación del basal (semana 0) con la semana 13 (± 5 días).
    2. Correlación entre los criterios de valoración por imagen [FRI (siVaw, iVlung, iVlobe, iVaww, atrapamiento aéreo, iRaw, BVX, IAD, mapeo de la ventilación y mapeo de la ventilación/perfusión) y puntuación de los tapones mucosos] y el volumen espiratorio forzado en 1 segundo antes del broncodilatador (pre-BD FEV1) en la semana 0.
    Correlación entre los criterios de valoración por imagen [criterios de valoración FRI y puntuación de tapones los mucosos] y la capacidad vital forzada antes del broncodilatador (pre-BD FVC) en la semana 0.
    Gráficas de dispersión (scatter plots) de los criterios de valoración FRI y de la puntuación de los tapones mucosos frente a las medidas convencionales de la función pulmonar (pre-BD FEV1 y pre-BD FVC) en la semana 0.
    Aumentos en los criterios de valoración FRI y en la puntuación de los tapones mucosos estimados por cada 1% de asociación entre el pre-BD FEV1 y la pre-BD FVC en la semana 0.
    3. Correlación entre el cambio desde la semana 0 en los criterios de valoración por imagen [criterios de valoración FRI y puntuación de los tapones mucosos] a la semana 13 y cambio desde la semana 0 en el pre-BD FEV1 a la semana 13 (± 5 días), en conjunto y por subgrupos, dependiendo del valor basal del pre-BD FEV1.
    Correlación entre el cambio desde la semana 0 en los criterios de valoración por imagen [criterios de valoración FRI y puntuación de los tapones mucosos] a la semana 13 y cambio desde la semana 0 en la pre-BD FVC a la semana 13 (± 5 días), en conjunto y por subgrupos, dependiendo del valor basal de la pre-BD FVC.
    Gráficas de dispersión de los cambios desde la semana 0 en los criterios de valoración FRI y la puntuación de los tapones mucosos a la semana 13 vs. los cambios desde la semana 0 en las medidas convencionales de la función pulmonar (pre-BD FEV1 y pre-BD FVC) a la semana 13.
    Cambio observado a lo largo del tiempo (semana 13 vs. semana 0) en los criterios de valoración FRI y la puntuación de los tapones mucosos, con y sin ajuste por las medidas convencionales de la función pulmonar (pre-BD FEV1 y pre-BD FVC).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Comparing baseline (week 0) to week 13 (± 5 days)
    2. At baseline (week 0)
    3. Comparing baseline (week 0) to week 13 (± 5 days)
    1. Comparación entre el valor basal (semana 0) y la semana 13 (± 5 días)
    2. En el momento basal (semana 0)
    3. Comparación entre el valor basal (semana 0) y la semana 13 (± 5 días)
    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 No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    An interventional single group, open-label, uncontrolled, prospective, multicenter clinical trial.
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    United States
    Netherlands
    Spain
    Belgium
    United Kingdom
    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
    The end of the study is defined as the date of the last expected visit/contact of the last participant undergoing the study.
    El fin del estudio se define como la fecha de la última visita/contacto previsto del último participante en el estudio.
    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 months5
    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 months5
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 199
    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
    Ninguno
    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 Decision2022-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-28
    P. End of Trial
    P.End of Trial StatusOngoing
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