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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-006951-32
    Sponsor's Protocol Code Number:REP0321
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-01-27
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-006951-32
    A.3Full title of the trial
    Reparixin 1200 mg three times a day as add-on therapy to standard of care to limit disease progression in hospitalised adult patients with COVID-19. A multinational, multicentre, randomised, double blinded, placebo-controlled, parallel-group phase III trial.
    Reparixin 1200 mg tre volte al giorno come terapia aggiuntiva allo standard of care per limitare la progressione della malattia in pazienti adulti ospedalizzati per COVID-19. Studio di fase III a gruppi paralleli, internazionale, multicentrico, randomizzato, doppio cieco, controllato con placebo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Reparixin 1200 mg three times a day as add-on therapy to standard of care to limit disease progression in hospitalised adult patients with COVID-19
    Repaxirin 1200 mg tre volte al giorno come terapia add-on alla terapia standard al fine di limitare la progressione del COVID-19 in pazienti adulti ospedalizati
    A.3.2Name or abbreviated title of the trial where available
    REP0321 Fase 3
    REP0321 Fase 3
    A.4.1Sponsor's protocol code numberREP0321
    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 SponsorDOMPé FARMACEUTICI S.P.A.
    B.1.3.4CountryItaly
    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 supportDompe Farmaceutici S.p.A:
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDompé farmaceutici s.p.a.
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressVia Santa Lucia 6
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number023408825229
    B.5.5Fax number0258383324
    B.5.6E-mailgiovanna.dituri@dompe.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.3.1Product nameRepaxirin
    D.3.2Product code [DF1681Y]
    D.3.4Pharmaceutical form 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 INNREPARIXIN
    D.3.9.1CAS number 266359-83-5
    D.3.9.2Current sponsor codeDF1681Y
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 placeboTablet
    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
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to evaluate the efficacy of oral reparixin plus standard of care versus placebo plus standard of care in limiting disease progression in adult patients hospitalized for severe COVID-19.
    Valutare l’efficacia del trattamento di reparixin per via orale rispetto allo standard of care nel limitare progressione della malattia in pazienti adulti ricoverati per COVID-19
    E.2.2Secondary objectives of the trial
    Secondary objectives. To determine the effect of reparixin on several disease severity/progression measures including recovery, ventilatory free days and mortality.
    Safety objectives. To evaluate the safety of oral reparixin versus placebo in the specific clinical setting.
    Obiettivo secondario determinare l’effetto di reparixin rispetto a diverse misurazioni di severità/ progressione della malattia (inclusi il recupero, I giorni liberi da ventilazione e la mortalità). Valutare la sicurezza di repaxirina orale verso placebo nello specifico setting clinico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent signed
    2. Male and female > o =18 years old;
    3. Patients hospitalized for SARS-CoV-2 infection RT-PCR-confirmed in the previous 10 days;
    4. Need for non-invasive supplemental oxygen (NIAID-OS 5-6);
    5. Radiological infiltrates by chest imaging;
    6. SpO2 <94% at room air, or PaO2/FiO2 <300;
    7. At least one inflammatory marker above ULN (LDH; CRP; ferritin; D-dimer);
    8. Females of child-bearing potential and with an active sexual life must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception:
    a. Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after the last IMP dose
    b. A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit until 30 days after the last IMP dose
    c. A male sexual partner who agrees to use a male condom with spermicide
    d. A sterile sexual partner
    Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, with child-bearing potential, pregnancy test result must be negative before first drug intake
    1.Consenso informato firmato
    2. Uomo o donna adulti con età > o = 18 anni
    3. Pazienti ricoverati per infezione da SARS-CoV-2 confermata dalla PCR nei 10 giorni precedenti
    4. Necessità di ossigeno supplementare o supporto ventilatorio non invasivo (NIAID-OS 5-6)
    5. Infiltrazioni radiologiche mediante imaging del torace
    6. SpO2 <94% in aria ambiente (o PaO2/FiO2 <300)
    7. Almeno un marker infiammatorio sopra al limite superiore di normalità (ULN): lattato deidrogenasi (LDH); proteina C-reattiva (CRP), ferritina, D-dimero)
    8. Le donne in età fertile e con una vita sessuale attiva non devono desiderare una gravidanza entro 30 giorni dalla fine dello studio e devono utilizzare almeno uno dei seguenti metodi contraccettivi affidabili:
    a. Contraccezione ormonale, contraccettivi sistemici, impiantabili, transdermici o iniettabili da almeno 2 mesi prima della visita di screening e fino a 30 giorni dopo l'ultima dose del prodotto medicinale in sperimentazione (IMP)
    b. Un dispositivo intrauterino non ormonale [IUD] o preservativo femminile con spermicida o spugna contraccettiva con spermicida o diaframma con spermicida o cappuccio cervicale con spermicida da almeno 2 mesi prima della visita di screening e fino a 30 giorni dopo l'ultima dose di IMP
    c. Un partner sessuale maschile che accetta di usare un preservativo maschile con spermicida
    d. Un partner sessuale sterile
    Saranno ammesse partecipanti di sesso femminile non in età fertile o in post-menopausa da almeno 1 anno. Per tutti i soggetti di sesso femminile, con potenziale di gravidanza, il risultato del test di gravidanza deve essere negativo prima
    della prima assunzione del farmaco
    E.4Principal exclusion criteria
    1. Treatment with IMV or ECMO (NIAID-OS 7);
    2. Hepatic dysfunction: ALT or AST > 5 ULN; history of chronic hepatic disease (defined with ChildPugh score B or C);
    3. Renal dysfunction: estimated glomerular filtration rate (eGFR, MDRD) <50 mL/min/1.73 m2, or need for haemodialysis or hemofiltration;
    4. PaO2/FiO2 ratio < 100 mmHg;
    5. Treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period;
    6. Anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening
    7. History of:
    a. intolerance or hypersensitivity to ibuprofen to more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib (hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole does not qualify for exclusion)
    b. lactase deficiency, galactosemia or glucose-galactose malabsorption
    c. gastrointestinal bleeding or perforation due to previous NSAIDs therapy or recurrent peptic ulcer/haemorrhage
    8. Active bleeding or bleeding diathesis (excluding menses), prior intracranial haemorrhage
    9. Participation in other interventional clinical trials
    10. Clinical condition not compatible with oral administration of the study drug
    11. Pregnancy:
    a) positive or missing pregnancy test before first drug intake or day 1;
    b) pregnant or lactating women;
    Women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study
    1.Trattamento con IMV o ECMO (NIAID-OS 7)
    2. Disfunzione epatica: ALT o AST > 5 ULN; storia di malattia epatica cronica (definita con punteggio B o C di Child-Pugh)
    3. Disfunzione renale: tasso stimato di filtrazione glomerulare (eGFR; MDRD) <50 mL/min/1.73 m2, o necessità di emodialisi o emofiltrazione;
    4. Rapporto PaO2/FiO2 < 100 mmHg
    5. Trattamento con un farmaco proibito entro 5 emivite, e incapacità di smettere durante il periodo di trattamento (5.5.2)
    6. Dimissione anticipata dall'ospedale o trasferimento in un altro ospedale entro 72 ore dallo screening
    7. Storia di:
    a. intolleranza o ipersensibilità all'ibuprofene, a più di un farmaco appartenente alla classe dei sulfamidici, come sulfametazina, sulfametossazolo, sulfasalazina, nimesulide o celecoxib (l'ipersensibilità ai soli antibiotici sulfanilamidici, ad esempio il sulfametossazolo non rientra nell'esclusione)
    b. carenza di lattasi, galattosemia o malassorbimento di glucosio galattosio
    c. emorragia gastrointestinale o perforazione dovuta a precedente terapia con FANS o ulcera peptica/emorragia ricorrente
    8. Emorragia attiva o diatesi emorragica (escluse le mestruazioni), precedente emorragia intracranica
    9. Partecipazione in altri studi clinici interventistici.
    10. Condizioni cliniche non compatibili con la somministrazione orale del farmaco in studio
    11. Gravidanza:
    a) test di gravidanza positivo o mancante prima della prima assunzione del farmaco o del giorno 1;
    b) donne incinte o in allattamento;
    Donne in età fertile e uomini fertili che non accettano di usare almeno una forma primaria di contraccezione per tutta la durata dello studio
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is the proportion of patients requiring IMV (or ECMO) by day 28 [NIAID-OS 7]
    L'endpoint primario è la percentuale di pazienti che richiedono IMV (o ECMO) entro il giorno 28 [NIAID-OS 7]
    E.5.1.1Timepoint(s) of evaluation of this end point
    By day 28
    Entro il giorno 28
    E.5.2Secondary end point(s)
    Key secondary endpoints:
    The following key secondary endpoints will be considered:
    1. Proportion of patients recovered (downward shift from screening of < or =2 points on the NIAID-OS or live discharge from hospital) [timeframe: day 28]
    2. Proportion of patients worsening (upward shift from screening of at least > or =1 point of the NIAID-OS) [timeframe: day 28]
    3. Ventilatory-free days (VFD) [timeframe: day 28] Number of days from Day 0 to Day 28 when the patient will alive and free of invasive ventilation. In case of multiple periods of IMV during the first 28 days, the total duration of ventilation considered all periods of ventilation during the index admission. Patients who will die within 28 days or will be still on invasive ventilation after 28 days will score zero VFDs.
    4. Incidence of secondary infections [timeframe: day 28]
    o Microbiologically confirmed infections, other than COVID-19, that will develop to day 28 and do not appear to be incubating at the time of inclusion,
    5. All-cause mortality [timeframe: day 28]
    Other secondary endpoints:
    In addition, the following secondary endpoints will be assessed:
    - ICU-free days [timeframe: day 28]
    - Days free of IMV/ECMO (number of days with NIAID-OS 1-5) [timeframe: day 28]
    - Hospital free days [timeframe: day 28]
    - Proportion of patients recovered (downward shift from screening of < or =2 points on the NIAID-OS or live discharge from hospital) [timeframe: day 3, 7±1, 14±2, 21±2 or at hospital discharge]
    - Proportion of patients worsening (upward shift from screening of at least > or = 1 point of the NIAID-OS) [timeframe: day 3, 7±1, 14±2, 21±2 or at hospital discharge]
    - PO2/FiO2 [timeframe: day 3, 7±1, 14±2, 21±2, 28 ±2 or at hospital discharge]
    - All-cause mortality [day 14 and 60]
    - Time to discharge or to a NEWS of < or = 2 (for 24 hours), whichever occurs first [timeframe: day 28]
    - Change in inflammatory markers (LDH, CRP, ferritin; D-dimer) and cytokines [timeframe: baseline - end of treatment]
    Endpoint secondari:
    I seguenti endopoint secondari saranno considerati:
    1. Proporzione di pazienti guariti (spostamento verso il basso dallo screening di < o =2 punti del NIAID-OS o dimissione dall'ospedale).
    2.Percentuale di pazienti in peggioramento (spostamento verso l'alto dallo screening di almeno > o = 1 punto del NIAID-OS).
    3.Giorni senza ventilazione [tempo Giorno 28] Numero di giorni dal giorno 0 al giorno 28 in cui il paziente sarà vivo e non sarà sottoposto a ventilazione invasiva. In caso di più periodi di IMV durante i primi 28 giorni, la durata totale della ventilazione ha considerato tutti i periodi di ventilazione durante l'indice di ricovero. I pazienti che moriranno entro 28 giorni o saranno ancora in ventilazione invasiva dopo 28 giorni otterranno zero VFD.
    4. Incidenza di infezioni secondarie.[tempo Giorno 28]. Infezioni confermate microbiologicamente, diverse da COVID-19, che si svilupperanno al giorno 28 e non sembrano essere in incubazione al momento dell'inclusione,
    5. Mortalità per tutte le cause.
    Altri endpoint secondari di efficacia:
    - Numero di giorni non in Unità di Terapia Intensiva al giorno 28.
    - Giorni senza IMV/ECMO (numero dei giorni con NIADS-OS da 1-5) al giorno 28.
    - Numero di giorni da non ricoverato al giorno 28.
    - Proporzione di pazienti guariti (spostamento verso il basso dallo screening di < o = 2 punti sul NIAID-OS o dimissione dall'ospedale) al giorno 3, 7±1, 14±2, 21±2 o alla dimissione dall'ospedale.
    - Percentuale di pazienti in peggioramento (spostamento verso l'alto dallo screening di almeno > o = 1 punto del NIAID-OS) al giorno 3, 7±1, 14±2, 21±2 o alla dimissione ospedaliera.
    - Rapporto PaO2/FiO2, al giorno 3, 7±1, 14±2, 21±2, 28±2 o alla dimissione dall'ospedale.
    - Mortalità per tutte le cause, al giorno 14 e al giorno 60.
    - Tempo fino alla dimissione o a una NEWS di < o = 2 (per 24 ore), a seconda di cosa si verifica prima.[tempo Giorno 28]
    - Marcatori infiammatori (LDH, CRP, ferritina, D-dimero) e citochine [basale - fine del trattamento].
    E.5.2.1Timepoint(s) of evaluation of this end point
    According to the protocol
    In accordo al protocollo
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Austria
    Bulgaria
    Germany
    Italy
    Poland
    United States
    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 assessment of the last patient
    Ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days29
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 450
    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 completion of the 60-day assessment or at study termination (for any other reason), patients will receive post-study care as prescribed by their non-study health care provider. No post-study or post study-termination treatment will be provided by the study team or Dompé.
    Dopo il completamento della valutazione di 60 giorni o al termine dello studio (per qualsiasi altro motivo), i pazienti riceveranno l'assistenza post-studio come prescritto dal loro medico di fiducia. Nessun trattamento post-studio o dopo la conclusione dello studio sarà fornito dal team dello studio o da Dompé.
    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 Decision2022-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-09-09
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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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