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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   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:2009-015878-35
    Sponsor's Protocol Code Number:BAY63-2521/14308
    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:2010-01-18
    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 number2009-015878-35
    A.3Full title of the trial
    Randomized, double blind, placebo controlled, parallel group, multi-center study to evaluate the hemodynamic effects of Riociguat (BAY 63-2521) as well as safety and kinetics in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

    Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar los efectos hemodinámicos de Riociguat (BAY 63-2521), así como la seguridad y la farmacocinética en pacientes con hipertensión pulmonar asociada a una disfunción sistólica del ventrículo izquierdo
    A.3.2Name or abbreviated title of the trial where available
    LEPHT
    A.4.1Sponsor's protocol code numberBAY63-2521/14308
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBayer Healthcare AG
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.1Product nameBAY 63-2521/Riociguat
    D.3.2Product code BAY 63-2521
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNRiociguat
    D.3.9.2Current sponsor codeBAY 63-2521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBAY 63-2521/Riociguat
    D.3.2Product code BAY 63-2521
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNRiociguat
    D.3.9.2Current sponsor codeBAY 63-2521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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: 3
    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.3.1Product nameBAY 63-2521/Riociguat
    D.3.2Product code BAY 63-2521
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNRiociguat
    D.3.9.2Current sponsor codeBAY 63-2521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pacientes sintomáticos con una hipertensión pulmonar asociada a una disfunción del ventrículo izquierdo (PH-sLVD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10037406
    E.1.2Term Pulmonary hypertension secondary
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El obejtivo principal del estudio es evaluar el perfil hemodinámico de Riociguat en pacientes con hipertensión pulmonar sintomática asociada a disfunción sistólica del ventrículo izquierdo (PH-sLVD).
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios son evaluar la seguridad, tolerabilidad y perfil farmacocinético de Riociguat en pacientes con hipertensión pulmonar sintomática asociada a disfunción sistólica del ventrículo izquierdo (PH-sLVD), y explorar dosis y posibles criterios de valoración para la fase III.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    El protocolo ampliado para ecografia es un subestudio que se llevará a cabo en los centros seleccionados.
    La prueba de esfuerzo cardiopulmonar es un subestudio que se llevará a cabo en los centros seleccionados: el titulo es prueba de esfuerzo cardiopulmonar (PECP) en pacientes con hiperstensión pulmonar asociada a disfunción sistólica del ventrículo izquiero (PH-sLVD). PECP puede proporcionar los suficientes parámetros para describir la respuesta clínica en diversas poblaciones de pacientes. Además, a parte de las pruebas de esfuerzo/ejercicio como la prueba de marcha de 6 minutos (6MWD) los parámetros obtenidos por CPET permiten pronósticos e implicaciones fundamentadas.
    E.3Principal inclusion criteria
    Los pacientes deben satisfacer los siguientes criterios para ser elegibles para este estudio:
    - Edad de 18 a 75 años en el momento del consentimiento informado
    (El límite inferior de edad puede ser superior, si así lo requieren las leyes de los países participantes)
    - Pacientes de ambos sexos con PH-sLVD sintomática (grupo 2/2.1 de la Clasificación de Dana Point y clases II-IV de la Organización Mundial de la Salud [OMS]) debida a cardiopatía isquémica o cardiomiopatía dilatada (CMD). Pueden incluirse los candidatos a trasplante.
    (Otros grupos de hipertensión pulmonar, especialmente HPTEC, deben descartarse conforme a los procedimientos diagnósticos y normas aceptados, véase el apartado 5.1.2 Criterios de exclusión)
    La PH-sLVD se define como:
    - FEVI < 40%, diagnosticada por ecocardiografía, ventriculogammagrafía o examen de cateterismo cardiaco izquierdo (CCI) en los 30 días anteriores a la aleatorización
    - PAPmedia >= 25 mmHg en reposo, medida por cateterismo cardiaco derecho (CCD)
    - Los pacientes deben ser tratados previamente, con ajuste máximo de la dosis individualmente, con tratamiento para ICC optimizado conforme a las normas de la Sociedad Europea de Cardiología (ESC) (9), del Colegio Americano de Cardiología/Asociación Americana del Corazón (ACC/AHA) (10) o de la Sociedad Japonesa de la Circulación (11) con inhibidores de la enzima convertidora de la angiotensina (IECA) o antagonistas de los receptores de la angiotensina (ARA), beta-bloqueantes y antagonistas del receptor de mineralocorticoides (RM), según indicación clínica. La pauta posológica debe ser estable durante > 30 días antes de la aleatorización. El tratamiento con diuréticos debe ser estable durante >= 1 semana antes de realizar el CCD basal.
    - Resultados de la CCD para el diagnóstico establecido de HP de no más de 1 semana en la visita 1. El CCD debe realizarse en el centro participante en condiciones normalizadas (consulte el manual de cateterismo de Swan Ganz específico del estudio).
    - Resultados del cateterismo cardiaco izquierdo disponibles en cualquier momento antes del inicio del estudio para valorar si la cardiopatía izquierda está causada por cardiopatía isquémica o cardiomiopatía dilatada.
    - Realización de una prueba de esfuerzo negativa < 1 año antes de la aleatorización conforme a las normas (electrocardiogradía [ECG] de esfuerzo, ecocardiografía de esfuerzo, gammagrafía de esfuerzo) para descartar una isquemia sintomática o asintomática.
    - Las mujeres son elegibles si no están en edad fértil, definido como:
    - mujeres posmenopáusicas (es decir, última hemorragia menstrual al menos 2 años antes del inicio del estudio)
    - mujeres con ligadura bilateral de trompas
    - mujeres con ovariectomía bilateral
    - mujeres con histerectomía
    o, si están en edad fértil, las mujeres son elegibles si
    - presentan una prueba de embarazo en suero resulta negativa en la visita previa al estudio, y
    - utilizan una combinación de preservativo y un método anticonceptivo seguro y muy eficaz (anticoncepción hormonal con implantes o anticonceptivos orales combinados, determinados dispositivos intrauterinos) durante todo el estudio.
    - El sujeto es capaz de entender y seguir las instrucciones y de participar en el estudio durante todo el periodo
    - Consentimiento informado por escrito
    E.4Principal exclusion criteria
    -HP en grupos distintos al grupo 2.1 conforme a la clasificación de Dana Point (1). En particular, debe haberse descartado HPTEC conforme a los procedimientos diagnósticos y normas aceptados.
    - Descompensación cardiaca, tanto con hospitalización o visita a urgencias, <= 30 días antes de la aleatorización
    - Tratamiento de resincronización iniciado <= 90 días antes de la aleatorización
    - Necesidad de diuréticos intravenosos (i.v.) <= 30 días antes de la aleatorización
    - Tratamiento con cardiotónicos o vasodilatadores i.v. <= 30 días antes de la aleatorización
    - Tratamiento previo con antagonistas del receptor de la endotelina (ARE), inhibidores de la fosfodiesterasa tipo 5 (PDE5) o prostanoides <= 30 días antes de la aleatorización, o con nitratos <= 7 días antes de la aleatorización
    - Los pacientes que precisan tratamiento farmacológico con fármacos que no siguen los criterios de inclusión o exclusión de este estudio o que son medicación concomitante prohibida (véase el apartado 6.9) en este estudio.
    - Asma bronquial o enfermedad pulmonar obstructiva crónica (EPOC) con volumen espiratorio máximo en un segundo (VEM1) < 60% del previsto
    - Enfermedad pulmonar restrictiva con capacidad pulmonar total (CPT) < 60% de la prevista
    - Pacientes bajo tratamiento con O2
    - Anomalías congénitas graves de pulmones, tórax o diafragma
    - Disfunción hepática clínicamente relevante caracterizada por:
    - Aspartato aminotransferasa (AST) >= 3 veces el límite superior normal (LSN)
    - Clasificación de Child Pugh B y C en pacientes cirróticos.
    - Insuficiencia renal severa (filtración glomerular [FG] < 30 ml/min calculada según la formula Modification of Diet in Renal Disease [MDRD] )
    - Hipertensión arterial no controlada (presión arterial sistólica [PAS] > 180 mmHg o presión arterial diastólica [PAD] > 110 mmHg)
    - PAS basal < 110 mmHg
    - Enfermedad miocárdica distinta a la isquémica o dilatada, como enfermedad miocárdica infiltrante (es decir, amiloidosis, cardiomiopatía hipertrófica)
    - Estenosis aórtica o mitral grave, o cualquier estenosis con indicación de cirugía
    - Arteriopatía coronaria con angina de clase III o IV de la Sociedad Cardiovascular Canadiense (CCS) o que precise nitratos, angina inestable o infarto de miocardio agudo menos de 90 días antes de la aleatorización
    - Procedimiento de reperfusión (intervención coronaria percutánea [ICP] o anastomosis arterial coronaria por injerto [CABG) menos de 90 días antes de la aleatorización o menos de 3 semanas en caso de un efecto negativo en la prueba del estrés después de ICP
    - Ictus con déficit neurológico persistente
    - Pacientes positivos al virus de la inmunodeficiencia humana (VIH)
    - Frecuencia cardiaca (FC) en reposo y despierto de < 50 latidos por minuto (LPM) o > 105 LPM (en caso de fibrilación auricular > 110 LPM)
    - Participación en otro ensayo clínico en los 90 días anteriores
    - Pacientes con un trastorno médico, enfermedad o antecedentes de ésta que a juicio del investigador podría alterar la capacidad del paciente para participar o finalizar el estudio principal de 4 meses
    - Pacientes con trastornos médicos subyacentes con una esperanza de vida prevista inferior a 2 años no debido a enfermedades cardiacas (es decir, un cáncer activo con masa tumoral localizada o metastásica)
    - Pacientes con antecedentes de alergias a varios fármacos
    - Pacientes con hipersensibilidad al fármaco en investigación o a cualquiera de los excipientes
    - Asignación anterior al tratamiento durante este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de la eficacia es el cambio respecto al valor basal de la presión arterial pulmonar media (PAPmedia) en reposo.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 Yes
    E.8.1.7.1Other trial design description
    the double blind phase of the trial will be followed by an open label extension phase
    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.8.3 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Last patient completed the study
    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 months6
    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 months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 130
    F.4.2.2In the whole clinical trial 180
    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)
    After the participation in the doublie blind phase, the subject will be asked to participate in an open-label extension phase until Riociguat received official approval.
    Detailed information on this extension open-label phase is provided in the study protocol
    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 Decision2010-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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