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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-004135-89
    Sponsor's Protocol Code Number:D516FC00001
    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:2021-12-03
    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 number2021-004135-89
    A.3Full title of the trial
    Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to Assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Participants with EGFR mutation positive Stage IA2-IA3 Non-small Cell Lung Cancer, following Complete Tumour Resection
    Estudio fase III, doble ciego, aleatorizado, controlado con placebo para evaluar la eficacia y seguridad del osimertinib en adyuvancia frente al placebo en pacientes con cáncer de pulmón de células macrociticas en estadio IA2-IA3 con mutación EGFR positiva, después de una resección tumoral completa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A late stage clinical trial to investigate the efficacy and safety of Osimertinib versus Placebo in patients with stage IA2-IA3 non-small cell lung cancer, following complete tumour resection.
    Ensayo clínico para investigar la eficacia y seguridad de Osimertinib versus Placebo en pacientes en estadío IA2-IA3 de cáncer de pulmón no microcítico, tras la resección completa del tumor.
    A.3.2Name or abbreviated title of the trial where available
    ADAURA2
    ADAURA2
    A.4.1Sponsor's protocol code numberD516FC00001
    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 supportAstraZenecaAB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressSerrano Galvache, 56; Parque Norte, Edificio Álamo
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900200444
    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 Yes
    D.2.1.1.1Trade name Tagrisso
    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.3.1Product nameOsimertinib 40 mg
    D.3.2Product code AZD9291
    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 INNosimertinib
    D.3.9.1CAS number 1421373-66-1
    D.3.9.2Current sponsor codeAZD9291
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.2.1.1.1Trade name Tagrisso
    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.3.1Product nameOsimertinib 80 mg
    D.3.2Product code AZD9291
    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 INNosimertinib
    D.3.9.1CAS number 1421373-66-1
    D.3.9.2Current sponsor codeAZD9291
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Stage IA2-IA3 non-small cell lung carcinoma, with EGFR mutation type (Ex19del, L858R), following complete tumour resection.
    Estadio IA2-IA3 de cáncer de pulmón no microcítico, positivo para la mutación de EGFR (Ex19del, L858R), tras la resección completa del tumor.
    E.1.1.1Medical condition in easily understood language
    Specific type of lung cancer called non-small cell lung cancer (NSCLC) stage IA2-IA3 with EGFR mutations positive after complete surgical removal of a tumour between 1 and 3 centimetres.
    Tipo específico de cáncer de pulmón no microcítico (CPNM) en estadío IA2-IA3 positivo para mutaciones de EGFR, tras la resección completa del tumor entre 1 y 3 centímetros.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029517
    E.1.2Term Non-small cell lung cancer stage I
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of osimertinib compared to placebo as measured by disease-free survival in participants in the high-risk statum.
    Demostrar la eficacia de osimertinib frente a placebo mediante la supervivencia libre de enfermedad (SLE) en pacientes del estrato de alto riesgo
    E.2.2Secondary objectives of the trial
    1. To demonstrate the effectiveness of osimertinib versus placebo by assessment of disease-free survival (DFS) in the overall population.
    2. To demonstrate the effectiveness of osimertinib versus placebo by assessment of overall survival (OS) in participants in both the high-risk stratum and the overall population.
    3. To assess the impact of osimertinib versus placebo on physical functioning in both the high-risk stratum and overall population.
    4. To assess the effectiveness of osimertinib versus placebo by assessment of central nervous system disease free survival (DFS) in both the high-risk stratum and the overall population.
    5. To characterise the pharmacokinetics of osimertinib and its metabolites (AZ13575104 [AZ5104]) in the overall population.
    6. To assess the safety and tolerability profile of osimertinib versus placebo in the overall population.
    1. Demostrar la eficacia de osimertinib frente a placebo en términos de SLE en la población general.
    2.Evaluar la eficacia de osimertinib frente a placebo en términos de supervivencia global (SG) en pacientes del estrato de alto riesgo.
    3. Evaluar el impacto de osimertinib frente a placebo en los resultados de CdVRS tanto en el estrato de alto riesgo como en la población general.
    4.Evaluar la eficacia de osimertinib frente a placebo en términos de SLE del SNC tanto en el estrato de alto riesgo como en la población general.
    5. Caracterizar la farmacocinética de osimertinib y sus metabolitos (AZ13575104 [AZ5104]) en la población general.
    6. Evaluar el perfil de seguridad y tolerancia de osimertinib frente a placebo en la población general.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, at least ≥ 18 years.
    2. NSCLC, of non-squamous histology.
    3. Stage IA2 or IA3 disease, based on TNM8 classification.
    4. Complete surgical resection (R0) of the primary NSCLC by lobectomy, segmentectomy or sleeve resection.
    5. Complete recovery from surgery at the time of randomisation. Study intervention cannot commence within 4 weeks following surgery. No more than 12 weeks may have elapsed between surgery and randomisation for participants.
    6. World Health Organization performance status of 0 or 1.
    7. Provision of tumour sample for central pathology assessment of pathologic risk factors and to assess EGFR mutation status prior to randomisation.
    8. A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R).
    9. Minimum life expectancy of > 6 months.
    10. Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential. Male subjects must be willing to use barrier contraception.
    1. Hombre o mujer, al menos ≥18 años.
    2. Cáncer de pulmón no microcítico (CPNM) de histología no escamosa.
    3. Enfermedad en estadio IA2 o IA3, según la clasificación TNM8.
    4.Resección quirúrgica completa (R0) del CPNM primario mediante lobectomía, segmentectomía o resección en manga.
    5. Recuperación completa de la intervención quirúrgica en el momento de la aleatorización. La intervención del estudio no puede comenzar en las 4 semanas posteriores a la intervención quirúrgica. No pueden haber transcurrido más de 12 semanas entre la intervención quirúrgica y la aleatorización de los participantes.
    6. Estado funcional según la Organización Mundial de la Salud de 0 o 1.
    7. Provisión de una muestra de tumor para la evaluación anatomopatológica central de los factores de riesgo patológicos y para evaluar el estado de mutación del EGFR antes de la aleatorización.
    8. Un tumor que alberga una de las 2 mutaciones del EGFR (Ex19del, L858R).
    9. Esperanza de vida mínima de >6 meses.
    10. Las mujeres deben utilizar métodos anticonceptivos altamente eficaces y presentar una prueba de embarazo negativa antes del inicio de la administración si están en edad fértil o deben presentar pruebas que demuestren que no están en edad fértil. Los sujetos varones deben estar dispuestos a utilizar métodos anticonceptivos de barrera.
    E.4Principal exclusion criteria
    1. Mixed small cell and non-small cell cancer history.
    2. Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy, bilobectomy or only wedge resection.
    3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and HIV.
    4. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence.
    5. Any of the following cardiac criteria:
    - Mean resting QTc interval > 470 ms, obtained from triplicate ECGs performed at screening,
    - Any abnormalities in rhythm, conduction, or morphology of resting ECG,
    - Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
    6. History of interstitial lung disease.
    7. Inadequate bone marrow reserve or organ function.
    8. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study intervention.
    9. Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs).
    10. Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention.
    11. Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A4.
    1. Antecedentes mixtos de cáncer microcítico y no microcítico.
    2. Participantes con resección incompleta (R1/R2) o que se hayan sometido a neumonectomía, bilobectomía o solo resección en cuña.
    3. Cualquier indicio de enfermedades sistémicas graves o no controladas, incluidas la hipertensión no controlada y la diátesis hemorrágica activa; o infección activa, incluidos hepatitis B, hepatitis C y VIH.
    4. Antecedentes de otra neoplasia maligna primaria, excepto neoplasia maligna tratada con intención curativa sin enfermedad activa conocida durante ≥5 años antes de la primera dosis de la intervención del estudio y de riesgo bajo de recidiva.
    5. Cualquiera de los siguientes criterios cardíacos:
    - Intervalo QTc medio en reposo >470 ms, obtenido de los electrocardiogramas (ECG) por triplicado realizados en la selección.
    - Cualquier anomalía en el ritmo, la conducción o la morfología del ECG en reposo.
    - Cualquier factor que aumente el riesgo de prolongación del intervalo QTc o el riesgo de acontecimientos arrítmicos.
    6. Antecedentes de enfermedad pulmonar intersticial.
    7. Función orgánica o reserva de médula ósea inadecuada.
    8. Cualquier toxicidad no resuelta del tratamiento previo que sea superior al grado 1 según los criterios terminológicos comunes para acontecimientos adversos (CTCAE) en el momento de iniciar la intervención del estudio.
    9. Tratamiento previo con cualquier tratamiento antineoplásico para el CPNM (incluidas quimioterapia, radioterapia, inmunoterapia e inhibidores de la tirosina [ITC] del EGFR).
    10. Intervención quirúrgica mayor o lesión traumática significativa en las 4 semanas anteriores a la primera dosis de la intervención del estudio.
    11. Participantes que actualmente reciben medicamentos o complementos a base de plantas que se sabe que son inductores potentes del CYP3A4.
    E.5 End points
    E.5.1Primary end point(s)
    Disease free survival (DFS) in the high-risk stratum by investigators' assessment.
    Supervivencia sin enfermedad (SSE) en el estrato de alto riesgo según la evaluación de los investigadores.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization until recurrence or death (by any cause in the absence of recurrence). Initial analysis in 2027.
    Desde la aleatorización hasta la recidiva o la muerte (por cualquier causa en ausencia de recidiva). Análisis inicial en 2027.
    E.5.2Secondary end point(s)
    - Disease free survival (DFS) in the overall population by investigator's assessment.
    - Disease free survival (DFS) in both the high-risk stratum and overall population.
    - Overall survival (OS) in participants in both the high-risk stratum and overall population.
    - Impact of osimertinib versus placebo on physical functioning in both the high-risk stratum and overall population.
    - Effectiveness of osimertinib versus placebo by assessment of central nervous system disease free survival (DFS) in both the high-risk stratum and the overall population.
    - Characterise the pharmacokinetics of osimertinib and its metabolites (AZ13575104 [AZ5104]) in the overall population.
    - Safety and tolerability profile of osimertinib versus placebo in the overall population.
    - Supervivencia sin enfermedad (SSE) en la población general según la evaluación del investigador.
    - Supervivencia sin enfermedad (SSE) en el estrato de alto riesgo y en la población general.
    - Supervivencia general (SG) en los participantes del estrato de alto riesgo y de la población general.
    - Impacto de osimertinib en comparación con el placebo en el funcionamiento físico en
    el estrato de alto riesgo y en la población general.
    - Eficacia de osimertinib en comparación con el placebo según la evaluación de la supervivencia sin enfermedad (SSE) en el sistema nervioso central en el estrato de alto riesgo y en la población general.
    - Caracterizar la farmacocinética de osimertinib y sus metabolitos (AZ13575104 [AZ5104]) en la población general.
    - Perfil de seguridad y tolerabilidad de osimertinib en comparación con el placebo en la población general.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the trial.
    A lo largo del ensayo.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Singapore
    Thailand
    Turkey
    Argentina
    Austria
    Brazil
    Canada
    China
    Germany
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    United Kingdom
    United States
    Vietnam
    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
    The last visit of the last patient undergoing the study
    La última visita del último paciente en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 190
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 380
    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)
    Patients will be treated in accordance with the local standard of care
    Los pacientes serán tratados de acuerdo a los tratamientos estándares locales.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-22
    P. End of Trial
    P.End of Trial StatusOngoing
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