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    The EU Clinical Trials Register currently displays   37700   clinical trials with a EudraCT protocol, of which   6177   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-004426-10
    Sponsor's Protocol Code Number:MO28072
    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:2012-01-19
    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 number2011-004426-10
    A.3Full title of the trial
    An open-label, phase II study of vemurafenib in patients with BRAF V600 mutation-positive cancers
    Estudio abierto fase II de vemurafenib en pacientes con neoplasias positivas para la mutación BRAF V600
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, phase II study of vemurafenib in patients with BRAF V600 mutation-positive cancers
    Estudio abierto fase II de vemurafenib en pacientes con neoplasias positivas para la mutación BRAF V600
    A.4.1Sponsor's protocol code numberMO28072
    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 SponsorF. Hoffman-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF.Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post codeCH-4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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.3.2Product code RO5185426/F17
    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 INNVEMURAFENIB
    D.3.9.1CAS number 918504-65-1
    D.3.9.2Current sponsor codeRO5185426-006
    D.3.9.3Other descriptive nameRG7204, PLX4032
    D.3.9.4EV Substance CodeSUB32161
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with cancers (excluding melanoma and papillary thyroid
    cancer) harboring BRAF V600 mutations as identified by the
    routinely performed mutation analysis assays at each individual
    participating site
    Pacientes con distintas neoplasias (exceptuando melanoma y cáncer papilar tiroideo) portadoras de mutaciones en BRAF V600, identificadas en análisis específicos para la detección de mutaciones, realizados de forma rutinaria en cada centro participante en el estudio
    E.1.1.1Medical condition in easily understood language
    Patients with cancers (excluding melanoma and papillary thyroid cancer) harboring BRAF V600 mutations.
    Pacientes con distintas neoplasias (exceptuando melanoma y cáncer papilar tiroideo) portadoras de mutaciones en BRAF V600
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008593
    E.1.2Term Cholangiocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    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 evaluate the efficacy of vemurafenib in patients with cancers harboring BRAF V600 mutations as response rate (RR) at Week 8 determined by the Investigator using Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST, v1.1) or International Myeloma Working Group (IMWG) uniform response criteria and to identify tumor types for further development
    Evaluar la eficacia de vemurafenib en pacientes con cánceres portadores de mutaciones en BRAF V600 basándose en el índice de respuesta (IR) alcanzado en la semana 8, que será determinado por el investigador utilizando los Criterios de Evaluación de la Respuesta en Tumores Sólidos, Versión 1.1 (RECIST, v1.1) o los criterios de respuesta uniforme del International Myeloma Working Group (IMWG), e identificar tipos de tumores para el futuro desarrollo clínico
    E.2.2Secondary objectives of the trial
    · To evaluate the safety and tolerability of vemurafenib in this
    patient population.
    · To evaluate in solid tumors and multiple myeloma (MM) overall response rate (ORR), clinical benefit rate (Clinical response (CR) or Stringent Complete Response (sCR)), partial response (PR) or very good partial response (VGPR) and stable disease [SD]) of vemurafenib, duration of response (DOR), time to response, time to tumor progression (TTP), progression free survival (PFS) and overall survival (OS).
    ?Evaluar la seguridad y la tolerancia de vemurafenib en esta población de pacientes.
    ?Evaluar, en pacientes con tumores sólidos y mieloma múltiple (MM), el índice de respuesta global (IRG), el índice de beneficio clínico [Respuesta clínica (RC) o Respuesta Completa estricta (RCe), Respuesta Parcial (RP) o Respuesta Pacial muy buena (RPMB) y estabilización de la enfermedad (EE)] de vemurafenib, la duración de la respuesta (DR), el tiempo hasta la respuesta, el tiempo hasta la progresión tumoral (TPT), la supervivencia libre de progresión (SLP) y la supervivencia global (SG).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For solid tumor cancer patients only:
    ?Histologically confirmed cancers (excluding melanoma and papillary thyroid cancer) that harbor a BRAF V600 mutation and are refractory to standard therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator
    ?Measurable disease according to RECIST, v1.1

    For multiple myeloma (MM) patients only:
    ?Patients with a confirmed diagnosis of MM and harbor a BRAF V600 mutation
    ?Patients must have received at least one line of prior systemic therapy for the treatment of MM. A line of treatment is sequential treatment without interruption for response and subsequent progression
    ?Patients treated with local radiotherapy (with or without concomitant exposure to steroids for pain control or management of cord/nerve root compression), two weeks must have lapsed since the last date of radiotherapy, which is recommended to be a limited field. Patients who require concurrent radiotherapy should have entry into the Study deferred until the radiotherapy is completed and two weeks have passed since the last date of therapy
    ?Patients must have relapsed and/or refractory MM with measurable disease, defined as disease that can be measured either by serum or urinary evaluation of the monoclonal component or by serum assay of free light chain (FLC) based on at least one of the following three measurements:
    oSerum M-protein > 0.5 g/dL
    oUrine M-protein > 200 mg per 24 hours
    oInvolved FLC level > 10 mg/dL (> 100 mg/L) provided serum FLC ratio is abnormal

    For all patients (solid tumors and MM patients):
    ?Male or female ? 18 years of age
    ?Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0?2
    ?Adequate hematologic, renal, and liver function
    Sólo para los pacientes con tumores sólidos:
    1. Cánceres confirmados histológicamente (exceptuando melanoma y cáncer papilar tiroideo) que son portadores de la mutación BRAF V600 y refractarios a tratamiento estándar o para los que no existe tratamiento estándar o curativo o éste no se considera apropiado, de acuerdo con el criterio del investigador
    2. Enfermedad medible, de acuerdo con los criterios RECIST, v1.1
    Sólo para los pacientes con mieloma múltiple:
    4. Pacientes con diagnóstico confirmado de MM que son portadores de la mutación BRAF V600
    5. Los pacientes deben haber recibido previamente al menos una línea de terapia sistémica para el tratamiento del MM. Una línea de terapia se define como el tratamiento secuencial administrado sin interrupción aunque se observe respuesta y posterior progresión de la enfermedad
    6. Si los pacientes han recibido radioterapia local (con o sin exposición concomitante a esteroides para el control del dolor o el manejo de la compresión de la médula espinal/raíz nerviosa), deben haber transcurrido dos semanas desde la fecha de la administración de la última sesión de radioterapia, que se recomienda que sea en un área limitada. En el caso de los pacientes que requieran radioterapia concomitante, se aplazará su inclusión en el estudio hasta que se haya completado la radioterapia y hayan transcurrido dos semanas desde la fecha de la última sesión de radioterapia
    7. Los pacientes deben presentar MM recurrente y/o refractario con enfermedad medible, que se define como aquella que se puede medir, o bien mediante el componente monoclonal en un análisis en suero u orina, o bien por un análisis en suero de los niveles de cadenas ligeras libres (CLL) basándose al menos en una de las tres determinaciones siguientes:
    a. Proteína M sérica > 0,5 g/dl
    b. Proteína M urinaria > 200 mg/24 horas
    c. Niveles de CLL involucrados > 10 mg/dl (> 100 mg/l), siempre que el ratio de FLC en suero sea anormal
    Para todos los pacientes (tumores sólidos y MM)
    9. Mujeres o varones ? 18 años de edad
    10. Estado funcional (EF) del Eastern Cooperative Oncology Group (ECOG) 0?2
    11. Función hematológica, renal y hepática adecuada
    E.4Principal exclusion criteria
    ?Melanoma, papillary thyroid cancer, or hematological malignancies (with the exception of multiple myeloma)
    ?Uncontrolled concurrent malignancy (early stage or chronic disease is allowed if not requiring active therapy or intervention and is under control)
    ?For MM, solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
    ?Active or untreated CNS metastases. Patients with brain metastasis are eligible if asymptomatic, off corticosteroid therapy and without evidence of disease progression in brain for ? 2 months.
    ?Concurrent administration of any anti-cancer therapies (e.g., chemotherapy, other targeted therapy, experimental drug, etc.) other than those administered in this study
    ?Prior treatment with a BRAF or MEK inhibitor (prior sorafenib is allowed)
    ?Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.
    Melanoma, cáncer papilar tiroideo o neoplasias hematológicas (exceptuando mieloma múltiple)
    Neoplasias concurrentes no controladas (está permitida la inclusión de pacientes con enfermedad en estadio inicial o crónica, si ésta no requiere terapia o intervención activa y está controlada)
    En pacientes con MM, plasmocitoma solitario óseo o extramedular como única evidencia de la discrasia de células plasmáticas
    Metástasis del SNC activas o no tratadas. Los pacientes con metástasis cerebrales son aptos para participar en el estudio si son asintomáticos, no están recibiendo tratamiento con corticosteroides, y no han manifestado indicios de progresión de la enfermedad a nivel cerebral durante ? 2 meses
    Administración concomitante de cualquier terapia anticancerosa (p. ej. quimioterapia, otros agentes dirigidos, fármacos en investigación, etc.) que no sea la utilizada en este estudio
    Tratamiento previo con un inhibidor de BRAF o MEK (está permitida la administración previa de sorafenib)
    Náuseas y vómitos refractarios, malabsorción, shunt biliar externo o resección intestinal significativa que impediría una absorción adecuada.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy of vemurafenib in patients with cancers harboring BRAF V600 mutations as response rate (RR) at Week 8 determined by the Investigator using Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST, v1.1) or International Myeloma Working Group (IMWG) uniform response criteria and to identify tumor types for further development
    Evaluar la eficacia de vemurafenib en pacientes con cánceres portadores de mutaciones en BRAF V600 basándose en el índice de respuesta (IR) alcanzado en la semana 8, que será determinado por el investigador utilizando los Criterios de Evaluación de la Respuesta en Tumores Sólidos, Versión 1.1 (RECIST, v1.1) o los criterios de respuesta uniforme del International Myeloma Working Group (IMWG), e identificar tipos de tumores para el futuro desarrollo clínico
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8 of vemurafenib treatment
    Semana 8 de tratamiento de vemurafenib
    E.5.2Secondary end point(s)
    To evaluate the safety and tolerability of vemurafenib in patients with cancers harboring BRAF V600 mutations. To evaluate in solid tumors and multiple myeloma (MM) overall response rate (ORR), clinical benefit rate (CR (or sCR), PR (or VGPR)) and stable disease [SD]),of vemurafenib, duration of response (DOR), time to response, time to tumor progression (TTP), PFS, and overall survival (OS).
    ?Evaluar la seguridad y la tolerancia de vemurafenib en esta población de pacientes.
    ?Evaluar, en pacientes con tumores sólidos y mieloma múltiple (MM), el índice de respuesta global (IRG), el índice de beneficio clínico [Respuesta clínica (RC) o Respuesta Completa estricta (RCe), Respuesta Parcial (RP) o Respuesta Pacial muy buena (RPMB) y estabilización de la enfermedad (EE)] de vemurafenib, la duración de la respuesta (DR), el tiempo hasta la respuesta, el tiempo hasta la progresión tumoral (TPT), la supervivencia libre de progresión (SLP) y la supervivencia global (SG).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Incidence of adverse events. Overall Response Rate / Tumor assessments according to RECIST Criteria 1 (RECIST, v1.1) or International Myeloma Working Group (IMWG) uniform response criteria.
    Incidencia de acontecimiento advesros. Tasa de Respuesta Global / evaluación de acuerdo con los criterios RECIST, v1.1 o los criterios de respuesta uniforme del International Myeloma Working Group (IMWG).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Identify tumor types for further development
    Identificar tipos de tumores para desarrollos posteriores
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other No
    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 trial8
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Germany
    Spain
    United Kingdom
    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
    The end of study will occur when all patients have been followed for survival for a maximum period of 12 months since last dose of study medication, have died, withdrawn consent, or are lost to follow up, whichever occurs first.
    El estudio terminará cuando se haya realizado un seguimiento de la supervivencia de todos los pacientes durante un máximo de 12 meses después de la administración de la última dosis del fármaco del estudio, hasta que se produzca la muerte, la retirada del consentimiento o la pérdida de seguimiento de los pacientes, dependiendo de lo que ocurra primero.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 61
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 121
    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 who develop disease progression but, in the opinion of the Investigator, would still benefit from continuing vemurafenib may continue treatment with vemurafenib after discussion with
    the Sponsor.
    Los pacientes que desarrollen progresión de la enfermedad pero que en opinión del investigador, podría beneficiarse continuando su tratamiento con vemurafenib, podria continuar el tratamiento con vemurafenib después de consultarlo con el promotor
    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 Decision2012-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-09
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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