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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2017-000373-36
    Sponsor's Protocol Code Number:997HA402
    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:2017-08-01
    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 number2017-000373-36
    A.3Full title of the trial
    A Non-controlled, Open-Label, Multicenter, Study of Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Subjects with Inhibitors Undergoing the First ITI Treatment
    Estudio abierto, multicéntrico y no controlado de la eficacia de rFVIIIFc para la inducción de tolerancia inmune (ITI) en sujetos con hemofilia A grave con inhibidores que se someten al primer tratamiento de ITI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study exploring the use of rFVIIIFc in patients with severe Haemophilia A who are undergoing Immune Tolerance Induction (ITI) for the first time
    Ensayo Clínico que explora el uso de rFVIIIFc en pacientes con Hemofilia A severa y que están bajo Immune Tolerance Induction (ITI) por primera vez
    A.4.1Sponsor's protocol code number997HA402
    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 SponsorBioverativ Therapeutics Inc.
    B.1.3.4CountryUnited States
    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 supportBioverativ Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioverativ Therapeutics Inc.
    B.5.2Functional name of contact pointN/A
    B.5.3 Address:
    B.5.3.1Street Address225 Second Avenue
    B.5.3.2Town/ cityWaltham, MA
    B.5.3.3Post code02451
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34913582211
    B.5.6E-mailclinicaltrials@bioverativ.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 ELOCTA
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum AB (publ)
    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 namerecombinant Factor VIII Fc
    D.3.2Product code rFVIIIFc
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEFMOROCTOCOG ALFA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeBIIB031
    D.3.9.3Other descriptive namerFVIIIFc, recombinant Factor FVIII Fc
    D.3.9.4EV Substance CodeSUB168409
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product 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
    Hemophilia A
    Hemofilia A
    E.1.1.1Medical condition in easily understood language
    Hemophilia A is a genetic disorder that impairs the body's ability to control blood clotting or coagulation, which is used to stop bleeding.
    La hemofilia A es un trastorno genético que afecta la capacidad del cuerpo para controlar la coagulación de la sangre, que se utiliza para detener el sangrado.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10060613
    E.1.2Term Hemophilia A (Factor VIII)
    E.1.2System Organ Class 100000011915
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10053751
    E.1.2Term Hemophilia A with anti factor VIII
    E.1.2System Organ Class 100000011928
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to describe the time to tolerance with rFVIIIFc in subjects within a maximum of 12 months ITI treatment.
    El objetivo principal del estudio es describir el tiempo hasta la tolerancia con rFVIIIFc en sujetos que reciben tratamiento de ITI durante un periodo máximo de 12 meses.
    E.2.2Secondary objectives of the trial
    •To describe the outcome of ITI treatment
    •To describe the relapse rate over the 48-week period following successful ITI performed with rFVIIIFc
    •To describe the intercurrent bleeding during ITI and during the 48-week period after successful ITI performed with rFVIIIFc
    •To describe safety and tolerability of rFVIIIFc when used for ITI
    •To evaluate the impact of ITI treatment with rFVIIIFc on health economics and adherence
     Describir el desenlace del tratamiento de ITI.
     Describir la tasa de recidivas durante el periodo de 48 semanas posterior a una ITI satisfactoria con rFVIIIFc.
     Describir las hemorragias intercurrentes durante la ITI y durante el periodo de 48 semanas posterior a una ITI satisfactoria con rFVIIIFc.
     Describir la seguridad y la tolerabilidad de rFVIIIFc cuando se emplea para la ITI.
     Evaluar el impacto del tratamiento de ITI con rFVIIIFc sobre la economía sanitaria y el cumplimiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Ability of the subject or his legally authorized representative (e.g., parent or legal guardian) to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
    2.Male subjects of any age diagnosed with severe hemophilia A (as confirmed from the medical record).
    3.Diagnosed with high titer inhibitors (historical peak ≥5 BU/mL, according to medical records)
    4.Previously treated with any plasma-derived or recombinant conventional or Extended Half-Life FVIII.
    1.Capacidad del sujeto o su representante legalmente autorizado (por ejemplo, padre o tutor legal) para entender el propósito y riesgos del estudio y proporcionar fechado y firmado el consentimiento informado y autorización para utilizar información de salud protegida con arreglo a las normas de privacidad nacional y local.
    2.Hombres sujetos de cualquier edad diagnosticados con hemofilia severa A (confirmado en la historia médica).
    3.Diagnosticado con títulos elevados de inhibidores (pico histórico ≥ 5 BU/mL, según registros médicos)
    4.Tratados previamente con cualquier derivado del plasma o recombinante convencional o Semivida prolongada FVII
    E.4Principal exclusion criteria
    1. Other coagulation disorder(s) in addition to hemophilia A.
    2. Previous ITI
    3. History of hypersensitivity or anaphylaxis associated with any rFVIIIFc administration.
    4. Planned major surgery to be deferred after study completion (minor surgery such as tooth extraction or insertion-replacement of central venous access device is allowed)
    5. Abnormal renal function (serum creatinine >2.0 mg/dL) as assessed by local laboratory.
    6. Serum alanine aminotransferase or aspartate aminotransferase >5 × upper limit of normal (ULN) as assessed by local laboratory.
    7. Serum total bilirubin >3 × ULN as assessed by local laboratory
    8. Previous registration in this study.
    9. Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 30 days (or 5 half-lives of the agent, whichever is longer) prior to the Baseline Visit.
    10. Inability to comply with study requirements.
    11. Presence of any medical or psychological condition or laboratory result that in the opinion of the Investigator can interfere with the subject’s ability to comply with the protocol requirements or makes the subject not appropriate for inclusion to the study and treatment with Elocta/Eloctate.
    12. Other unspecified reasons that, in the opinion of the Investigator or Bioverativ, make the subject unsuitable for enrollment.
    13. Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that prevents the subject from participating in visits as scheduled
    14. Concurrent systemic treatment with immunosuppressive drugs within 12 weeks prior to Screening. Exceptions to this include: ribavirin for treatment of hepatitis C virus (HCV), and/or systemic steroids (a total of 2 courses of pulse treatments lasting no more than 7 days within 12 weeks prior to Day 1) and/or inhaled steroids
    The following criteria refer to tests performed within 26 weeks prior to Screening. If not available, a new test should be drawn at the Screening visit.
    15. Cluster of differentiation 4 (CD4) lymphocytes >200 mm3 at Screening, if known as human immunodeficiency virus (HIV) antibody positive based on medical history or HIV testing
    16. Viral load of <400 copies/mL at Screening, if known HIV antibody positive, based on medical history.
    1.Otros trastornos en la coagulación además de la Hemofilia A.
    2.Previo ITI
    3.Historia de hipersensibilidad o anafilaxia asociada a cualquier administración de rFVIIIFc.
    4.Cirugía mayor planificada para ser diferida después de la terminación del estudio (se permite cirugía menor como extracción dental o inserción-reemplazo del dispositivo de acceso venoso central)
    5.Función renal anormal (creatinina sérica 2,0 mg/dL) según lo determinado por el laboratorio local.
    6.Suero alanina aminotransferasa o aspartato aminotransferasa 5 × límite superior de normal (ULN) según lo determinado por el laboratorio local.
    7.Suero bilirrubina total 3 × LSN según lo determinado por el laboratorio local
    8.Inscripción previa en este estudio.
    9.Inscripción actual o un plan para inscribirse en cualquier estudio clínico intervencionista en el que un tratamiento en fase de investigación o terapia aprobada para uso en investigación se administra dentro de 30 días (o 5 vidas medias del agente, lo que sea mayor) antes de la visita inicial.
    10. incapacidad de cumplir con los requisitos de estudio.
    11.Presencia de cualquier condición médica o psicologica o resuktado de laboratorio que en la opínión del Investigador pueda interferir con la habilidad de cumplir con los requerimientos del protocolo o hacer al sujeto no apropiado para la inclusión en el estudio y tratamiento con Elocta/Eloctato.
    12.Otras razones no especificadas que, en opinión del investigador o del Bioverativ, hagan al sujeto no apto para el reclutamiento.
    13.Falta de voluntad o incapacidad para cumplir con los requisitos del Protocolo, incluyendo la presencia de cualquier condición (física, mental o social) que impide que el sujeto participa en visitas programadas.
    14.Tratamiento sistémico concurrente con drogas inmunosupresivas dentro de 12 semanas antes de la proyección. Excepciones a esto: la ribavirina para el tratamiento del virus de la hepatitis C (VHC) o esteroides sistémicos (un total de 2 cursos de tratamiento de pulso durante no más de 7 días dentro de las 12 semanas antes del día 1) o los esteroides inhalados.
    Los siguientes criterios se refieren a pruebas realizadas dentro de las 26 semanas antes de la proyección. Si no está disponible, una nueva prueba debe ser realizada en la visita de selección.
    15. Grupo de diferenciación 4 (CD4) mm3 linfocitos 200 en evaluación, si conocido como anticuerpo del virus de inmunodeficiencia humana (VIH) positivo basado en historial médico o el VIH pruebas
    16.Carga viral de 400 copias/mL en proyección, si conoce VIH anticuerpo positivo, basado en historia clínica.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is time to tolerization with a maximum of 12 months ITI treatment offered in the study. (Tolerization defined as inhibitor titer <0.6BU/ml, FVIII recovery > 66% and t1/2 of ≥7hrs)
    La principal variable de este estudio es el tiempo hasta la tolerancia con un máximo de 12 meses de tratamiento de ITI ofrecido en el estudio. (Tolerancia definido como título inhibidor <0.6BU/ml, recuperación del FVIII del 66 % y t1/2 de ≥7 horas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint of time to tolerization will be summarized descriptively using minimum, mean, standard deviation, median, 25th and 75th quartiles, and maximum. A Kaplan-Meier plot showing percentage of subjects who are tolerized against time from the first ITI infusion will also be generated. Subjects not achieving ITI success during the 12 months ITI period will be censored at the last observed time for this analysis. The ITIFAS analysis set will be used for this analysis
    La variable primaria del tiempo de tolerancia se resumirá descriptivamente utilizando el mínimo, significa, desviación estándar, mediana, 25 y 75 cuartiles y máxima. También se generará una trama de Kaplan-Meier que muestra el porcentaje de sujetos que toleran frente al tiempo de la primera infusión de ITI. Sujetos que no logren el éxito ITI durante los 12 meses ITI serán censurados en la última observación en el momento del análisis. El sistema de análisis ITIFAS se utilizará para este análisis
    E.5.2Secondary end point(s)
    •ITI success
    oNegative titer for inhibitor (<0.6 BU/mL by the Nijmegen-modified Bethesda assay) in 2 consecutive determinations
    oFVIII incremental recovery (IR) >1.3 IU/dL per IU/kg in 2 consecutive determinations representing 66% of the expected IR 2 IU/dL per IU/kg (ref SmPC).
    oFVIII t1/2 ≥7 hours
    •Occurrence of relapse during a 48-week period following successful ITI treatment (defined as inhibitor titer >0.6 BU/mL or abnormal recovery after tolerance is achieved)
    •Number of bleeding episodes during ITI and during the 48-week period after successful ITI performed with rFVIIIFc
    •Treatment emergent adverse events (TEAE) and treatment emergent serious adverse events (TESAE)
    •Number of days away from work or school
    •Number of hospitalization days
    •Adherence (defined as percentage of administered doses versus planned doses)
    •Consumption of rFVIIIFc (measured in total rFVIIIFc use)
     Tasa de éxito de la ITI.
    o Título negativo del inhibidor (<0,6 UB/ml mediante el ensayo de Bethesda modificado por Nijmegen) en 2 determinaciones consecutivas.
    o Recuperación incremental (RI) del FVIII >1,3 UI/dl por UI/kg en 2 determinaciones consecutivas que represente el 66 % del RI previsto de 2 UI/dl por UI/kg (ver RCP).
    o t1/2 del FVIII ≥7 horas
     Aparición de recidiva durante un periodo de 48 semanas posterior a una ITI satisfactoria con rFVIIIFc (definida como un título de inhibidor >0,6 UB/ml o recuperación anómala después de desarrollar tolerancia).
     Número de episodios hemorrágicos durante la ITI y durante el periodo de 48 semanas posterior a una ITI satisfactoria con rFVIIIFc.
     Acontecimientos adversos surgidos durante el tratamiento (AAST) y acontecimientos adversos graves surgidos durante el tratamiento (AAGST).
     Número de días laborales o escolares perdidos.
     Número de días de hospitalización.
     Cumplimiento (definido como el porcentaje de dosis administradas frente a las dosis planificadas).
     Consumo de rFVIIIFc (medido en el uso total de rFVIIIFc).
    E.5.2.1Timepoint(s) of evaluation of this end point
    After Baseline Visit which is the start of ITI treatment, subjects will be seen at Week 2 and every fourth week until subjects acheive a negative inhibitor titer (<0.6 BU/mL). Starting at time of first negative inhibitor titer until ITI success OR 48 weeks of treatment, subjects will be seen every 2nd week. With ITI success (3 success criteria met) and continuing for 16 weeks (Tapering period), subjects will have assessment visits after 2 weeks, 4 weeks and then every 4th week thereafter. Follow-up Period constitutes the time period in which subject returns to prophylactic dosing regimen and will be approximately 32 weeks in duration.
    Después de la visita Basal, la cual es el inicio para el comienzo del tratamiento con ITI, los sujetos serán observados en la semana 2 y a la 4ª semana hasta que el sujeto alcance el título negativo del inhibidor (<0,6 UB/ml). Comenzando en el momento del Título negativo del inhibidor hasta el éxito con ITI OR 48 semanas de tratamiento. Se verá a los sujetos cada segunda semana. Con éxito de ITI (3 éxitos alcanzados que cumplan criterios) y continuando 16 semanas (Disminuyendo el período), sujetos tendrán visitas de evaluación después de 2 semanas, 4 semanas y luego cada 4 semana después de eso. Período de seguimiento constituye el período de tiempo en que vuelve sujeto a régimen de dosis profiláctica y será aproximadamente 32 semanas de duración.
    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 No
    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) 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 Yes
    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 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 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Belgium
    Canada
    European Union
    France
    Germany
    Italy
    Japan
    Puerto Rico
    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 is last subject, last visit for final collection of data.
    El final del ensayo es último sujeto, última visita para la recolección final de datos.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 30
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 27
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 2
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female No
    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 No
    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
    Parents/legal guardians of subjects must be provided with the informed consent information prior to the Screening Visit to allow adequate time for review and an opportunity to discuss the study with the Investigator/designee.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 30
    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
    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 Decision2017-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-16
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