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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   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:2022-000715-31
    Sponsor's Protocol Code Number:ACTIV-4
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-06-10
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2022-000715-31
    A.3Full title of the trial
    Clinical Trials targeting macro-, micro-immuno-thrombosis, vascular hyperinflammation, and hypercoagulability and renin-angiotensin-aldosterone system (RAAS) in hospitalized patients with COVID-19 (ACTIV-4 Host Tissue)
    Protocolo maestro para ensayos clínicos dirigido a macrotrombosis, microinmunotrombosis, hiperinflamación vascular e hipercoagulabilidad y el sistema renina-angiotensina-aldosterona (SRAA) en pacientes hospitalizados con COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Novel Experimental COVID Therapies Affecting Host Response (NECTAR)
    A.3.2Name or abbreviated title of the trial where available
    NECTAR
    A.4.1Sponsor's protocol code numberACTIV-4
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04924660
    A.5.4Other Identifiers
    Name:sIRB Study NumberNumber:210982
    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 SponsorNEAT ID
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institutes of Health (NIH)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationResearch Organisation (KC)
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressThe Stanley Building
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeN1C 4AG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+447508 439711
    B.5.6E-mailnectar@rokcservices.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.2.5The 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 nameFostamatinib
    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 INNFostamatinib
    D.3.9.3Other descriptive nameFOSTAMATINIB DISODIUM HEXAHYDRATE
    D.3.9.4EV Substance CodeSUB197641
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number126.2
    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.2.5The 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 nameFostamatinib
    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 INNfostamatinib
    D.3.9.3Other descriptive nameFOSTAMATINIB DISODIUM HEXAHYDRATE
    D.3.9.4EV Substance CodeSUB197641
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number189.3
    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
    COVID-19 viral infection
    Infección por el virus COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 viral infection
    Infección por el virus COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.1
    E.1.2Level LLT
    E.1.2Classification code 10085775
    E.1.2Term Laboratory confirmed COVID-19
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overarching goal of the trial is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19.

    The overarching objective of this platform is to iteratively test treatment strategies targeting the host tissue response for improving clinical outcomes among adults hospitalized with COVID-19. Treatment strategies will be added to the current best practice and tested against best practice plus placebo. Best practice may itself be updated as therapies become available or are shown to be effective (or ineffective).
    El objetivo general del protocolo maestro es encontrar estrategias eficaces para el tratamiento hospitalario de los pacientes con COVID-19. Los objetivos terapéuticos para los pacientes hospitalizados por COVID-19 incluyen acelerar la recuperación y prevenir la progresión a enfermedad crítica, fallo multiorgánico o muerte. Nuestro objetivo es determinar si la modulación de la respuesta del tejido huésped mejora los resultados clínicos entre los pacientes con COVID-19.

    El objetivo general de esta plataforma es probar iterativamente estrategias de tratamiento dirigidas a la respuesta del tejido del huésped para mejorar los resultados clínicos entre adultos hospitalizados con COVID-19. Las estrategias de tratamiento se agregarán a las mejores prácticas actuales y se probarán con las mejores prácticas más el placebo. Las mejores prácticas pueden actualizarse a medida que las terapias estén disponibles o se demuestre que son efectivas (o ineficaces).
    E.2.2Secondary objectives of the trial
    A further objective is to determine which of the different RAAS agents’ targets (AT1r biased agonist, Ang[1-7] infusion) and associated mechanisms of action, when added to current best practice and compared to current best practice plus placebo, result in an effective therapeutic approach to the RAAS system in patients infected with SARS-CoV-2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hospitalized for COVID-19
    2. ≥18 years of age
    3. SARS-CoV-2 infection, documented by:
    a. a nucleic acid test (NAT) or equivalent testing within 3 days prior to randomization OR
    b. documented by NAT or equivalent testing more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non-NAT tests is maintained in Appendix G.)
    4. Hypoxemia, defined as SpO2 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy
    5. Symptoms or signs of acute COVID-19, defined as one or more of the following:
    a. Cough
    b. Reported or documented body temperature of 100.4o F or greater
    c. shortness of breath
    d. chest pain
    e. infiltrates on chest imaging (x-ray, CT scan, lung ultrasound)
    1. Hospitalización por COVID-19
    2. ≥18 años de edad
    3. Infección por SARS-CoV-2, documentada por:
    a. una prueba de ácido nucleico (NAT) o pruebas equivalentes en los 3 días anteriores a la aleatorización O
    b. documentado por el NAT o pruebas equivalentes más de 3 días antes de la aleatorización Y enfermedad progresiva que sugiera infección por SARS-CoV-2 en curso según el investigador responsable (para las pruebas distintas del NAT, solo se permitirán aquellas consideradas con especificidad equivalente a la del NAT por el equipo del protocolo. En el Apéndice G se mantiene una lista central de las pruebas distintas del NAT permitidas).
    4. Hipoxemia, definida como SpO2 <92 % con aire ambiental, nueva recepción de oxígeno suplementario para mantener la SpO2 ≥92 %, o aumento de oxígeno suplementario para mantener la SpO2 ≥92 % para un paciente con tratamiento crónico con oxígeno
    5. Síntomas o signos de COVID-19 aguda, definidos como uno o más de los siguientes:
    a. tos
    b. temperatura corporal notificada o documentada de 100,4 oF (38 ºC) o superior
    c. fatiga (disnea o falta de aliento)
    d. dolor torácico
    e. infiltrados en las imágenes de tórax (radiografía, TAC, ecografía pulmonar)
    E.4Principal exclusion criteria
    1. COVID-19 symptom onset >14 days prior to randomization
    2. Hospitalized for >72 hours prior to randomization
    3. Pregnancy
    4. Breastfeeding
    5. Prisoners
    6. End-stage renal disease (ESRD) on dialysis
    7. Patient and/or clinical team is not pursuing full medical management (if a patient has a Do Not Resuscitate order that precludes chest compressions in the event of a cardiac arrest but is otherwise pursuing full medical management, he/she is eligible for this trial).
    8. The treating clinician expects inability to participate in study procedures or participation would not be in the best interests of the patient

    Fostamatinib Arm-Specific Exclusion Criteria:
    1. Randomized in another trial evaluating fostamatinib in the prior 30 days
    Fostamatinib Arm-Specific Exclusion Criteria measured within 24-hours prior to randomisation:
    1. AST or ALT ≥ 5 × upper limit of normal (ULN) or ALT or AST ≥ 3 × ULN and total bilirubin ≥ 2 × ULN
    2. SBP > 160 mmHg or DBP > 100 mmHg at the time of screening and randomization
    3. ANC < 1000/mL
    4. Patient requires use of strong CYP3A modulators from Table above (Clarithromycin, Indinavir, Itraconazole, Ketoconazole, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Telithromycin, Troleandomycin, Carbamazepine, Efavirenz, Enzalutamide, Modafinil, Nevirapine, Oxcarbazepine, Phenobarbital, Phenytoin, Rifabutin, Rifampin, St. John’s Wort, or Troglitazone).
    5. Patient unable to participate or declines participation in the fostamatinib arm.
    1. Aparición de los síntomas de COVID-19 >14 días antes de la aleatorización
    2. Hospitalizado durante >72 horas antes de la aleatorización
    3. Embarazo
    4. Lactancia
    5. Prisioneros
    6. Enfermedad renal terminal (ERT) en diálisis
    7. El paciente y/o el equipo clínico no están realizando un tratamiento médico completo (si un paciente tiene un orden de No reanimar que impida las compresiones del tórax en caso de parada cardiaca, pero por lo demás está realizando un tratamiento médico completo, es apto para este ensayo).
    8. El médico responsable del tratamiento cree que la incapacidad para participar en los procedimientos del estudio o la participación no es lo mejor para el paciente

    Criterios de exclusión específicos del brazo de fostamatinib:
    1. Aleatorizado en otro ensayo que evaluó fostamatinib en los 30 días anteriores
    Criterios de exclusión específicos del brazo de fostamatinib medidos dentro de las 24 horas previas a la aleatorización:
    1. AST o ALT ≥ 5 × límite superior de la normalidad (LSN) o ALT o AST ≥ 3 × LSN y bilirrubina total ≥ 2 × LSN
    2. PAS > 160 mmHg o PAD > 100 mmHg en el momento de la selección y la aleatorización
    3. RAN < 1000/mL
    4. El paciente requiere el uso de moduladores potentes de CYP3A de la tabla anterior (claritromicina, indinavir, itraconazol, ketoconazol, nefazodona, nelfinavir, ritonavir, saquinavir, telitromicina, troleandomicina, carbamazepina, efavirenz, enzalutamida, modafinilo, nevirapina, oxcarbazepina, fenobarbital, fenitoína, rifabutina , rifampicina, hierba de San Juan o troglitazona).
    5. El paciente no puede participar o rechaza participar en el brazo de fostamatinib.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome: Oxygen free days through day 28. This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die prior to day 28 are assigned -1 oxygen free days.
    Resultados principales:
    Días sin oxígeno hasta el día 28. Esto se define como días vivos y sin uso de oxígeno suplementario durante los primeros 28 días tras la aleatorización. A los pacientes que mueren antes del día 28 se les asigna -1 día sin oxígeno.
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 28
    día 28
    E.5.2Secondary end point(s)
    • Alive and oxygen free at days 14 and 28
    • Alive and respiratory failure-free at days 14 and 28
    • Alive and free of new invasive mechanical ventilation at 14 and 28 days
    • In-hospital, 28-day, 60-day and 90-day mortality
    • WHO 8-point ordinal scale at 14, 28 and 60 days
    • Support-free days to Day 28, including:
    Hospital-free days
    Respiratory failure-free days
    Ventilator-free days
    Resultados secundarios:
    • Mortalidad hospitalaria
    • Proporción de pacientes vivos y sin oxígeno en los días 14 y 28
    • Proporción de pacientes con nueva ventilación mecánica invasiva en el día 28
    • Mortalidad a los 28 días
    • Mortalidad a los 60 días
    • Mortalidad a los 90 días
    • Escala ordinal de 8 puntos de la OMS a los 14, 28 y 60 días
     1: Ambulatorio – no hospitalizado y sin limitación de las actividades
     2: Ambulatorio: no hospitalizado con limitación de actividades o uso de oxígeno en el hogar
     3: Enfermedad leve hospitalizada – hospitalizado, sin oxigenoterapia
     4: Enfermedad leve hospitalizada – hospitalizado, oxígeno mediante mascarilla o gafas nasales
     5: Enfermedad grave hospitalizada – Ventilación no invasiva o cánula nasal de alto flujo
     6: Enfermedad grave hospitalizada – Ventilación mecánica invasiva
     7: Enfermedad grave hospitalizada – Ventilación mecánica invasiva más soporte orgánico adicional con vasopresores, TSR o ECMO
     8: Muerto
    • Días sin asistencia hasta el día 28, que incluyen:
     Días sin hospital
     Días sin ventilación mecánica
     Días sin insuficiencia respiratoria
    E.5.2.1Timepoint(s) of evaluation of this end point
    days 60 and 90.
    días 60 y 90.
    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 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) Yes
    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 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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA500
    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
    Argentina
    Brazil
    South Africa
    France
    Spain
    Germany
    Italy
    United Kingdom
    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
    LVLS
    LVLS
    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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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
    This trial may include participants who have no capacity to consent but for whom a legally authorised representative may provide consent. If the participant regains the capacity to consent, they will be approached for reconsent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 800
    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
    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 Decision2022-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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