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    Summary
    EudraCT Number:2019-002895-14
    Sponsor's Protocol Code Number:APD334-202
    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:2021-01-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-002895-14
    A.3Full title of the trial
    A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease
    Studio di fase 2b, multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare l’efficacia e la sicurezza di etrasimod orale come terapia di induzione in soggetti affetti da malattia di Crohn da moderatamente a gravemente attiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease
    Studio per valutare l’efficacia e la sicurezza di etrasimod come terapia in pazienti affetti da malattia di Crohn da moderata a gravemente attiva
    A.3.2Name or abbreviated title of the trial where available
    APD334-202
    APD334-202
    A.4.1Sponsor's protocol code numberAPD334-202
    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 SponsorARENA PHARMACEUTICALS, 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 supportArena Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArena Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointTracy Angelly
    B.5.3 Address:
    B.5.3.1Street Address6154 Nancy Ridge Drive
    B.5.3.2Town/ citySan Diego - CA
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018582104524
    B.5.5Fax number000000
    B.5.6E-mailtangelly@arenapharm.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 nameEtrasimod
    D.3.2Product code [APD334]
    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 INNetrasimod L-arginine
    D.3.9.1CAS number 1206123-97-8
    D.3.9.2Current sponsor codeAPD334 L-arginine
    D.3.9.3Other descriptive nameAR401959 L-arginine
    D.3.9.4EV Substance CodeSUB171412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.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 nameEtrasimod
    D.3.2Product code [APD334]
    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 INNetrasimod L-arginine
    D.3.9.1CAS number 1206123-97-8
    D.3.9.2Current sponsor codeAPD334 L-arginine
    D.3.9.3Other descriptive nameAR401959 L-arginine
    D.3.9.4EV Substance CodeSUB171412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Crohn's Disease
    malattia di Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease a form of inflammatory bowel disease.
    malattia di Crohn una forma di malattia infiammatoria intestinale.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10011398
    E.1.2Term Crohn's
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo as induction therapy in subjects with moderately to severely active Crohn's disease (CD).
    To select an oral etrasimod dose, based on efficacy and safety, for continued development.
    Valutare il rapporto dose-risposta di 2 dosi di etrasimod rispetto al placebo come terapia di induzione in soggetti con malattia di Crohn (MC) da moderatamente a gravemente attiva.
    Selezionare una dose di etrasimod orale, in base all’efficacia e alla sicurezza, per il prosieguo dello sviluppo.
    E.2.2Secondary objectives of the trial
    To evaluate the long-term safety, tolerability, and efficacy of etrasimod in subjects with moderately to severely active Crohn's disease (CD).
    Valutare la sicurezza, la tollerabilità e l’efficacia a lungo termine di etrasimod in soggetti con MC da moderatamente a gravemente attiva.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women 18 to 80 years of age
    2. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
    3. Diagnosed with CD >= 3 months
    4.Have moderately to severely active CD at Screening
    5.Demonstrated inadequate response, loss of response to, or intolerance to >= 1 of the following therapies for the treatment of CD:
    a.Oral corticosteroids (eg, prednisone or its equivalent, budesonide)
    b.Immunosuppressants (eg, azathioprine [AZA], 6 mercaptopurine [6 MP], or methotrexate [MTX])
    c.Tumor necrosis factor alpha (TNFa) antagonists (eg, infliximab,adalimumab, certolizumab pegol, or biosimilars)
    d.Integrin receptor antagonist (eg, vedolizumab)
    e.Interleukin 12/ 23 antagonist (eg, ustekinumab)
    6.Females of childbearing potential must be nonpregnant
    7.Females of childbearing potential and males must use contraception
    1. Soggetti di età compresa tra 18 e 80 anni,
    2. Capacità di fornire il consenso informato scritto e di attenersi al programma delle valutazioni previste dal protocollo.
    3. MC in corso da >= 3 mesi
    4. Presenza di MC da moderatamente a gravemente attiva allo screening
    5. Dimostrazione di risposta inadeguata, perdita di risposta o intolleranza a >=1 delle seguenti terapie per il trattamento della MC:
    a. corticosteroidi orali (ad es., prednisone o equivalente, budesonide);
    b. immunosoppressori (ad es., azatioprina [AZA], 6-mercaptopurina [6-MP] o metotrexato [MTX]);
    c. antagonisti del fattore di necrosi tumorale alfa (TNFa) (ad es., infliximab, adalimumab, certolizumab pegol o biosimilari);
    d. antagonista del recettore dell’integrina (ad es., vedolizumab);
    e. antagonista dell’interleuchina 12/ 23 (ad es., ustekinumab).
    6. I soggetti di sesso femminile in età fertile non devono essere in stato di gravidanza
    7. I soggetti di sesso femminile in età fertile e i soggetti di sesso maschile devono utilizzare contraccezione
    E.4Principal exclusion criteria
    - History of inadequate response (ie, primary non response) to agents from >=2 classes of biologics marketed for the treatment of CD (ie, TNFa antagonists, interleukin 12/ 23 antagonist, and integrin receptor
    antagonist).
    - Have ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, toxic megacolon, or active infectious colitis or test positive for Clostridium difficile toxin at Screening.
    - Have functional or post operative short bowel syndrome or any associated complications that may require surgery or interfere with efficacy assessments
    - Had surgical treatment for intra abdominal abscesses <=8 weeks prior to randomization or surgical treatment for perianal abscesses <=4 weeks prior to randomization.
    - Had intestinal resection <=24 weeks prior to randomization or other intra abdominal surgeries <=12 weeks prior to randomization.
    - Have an ileostomy or a colostomy.
    - Have a serious infection requiring IV antibiotics/medication(s) <=4 weeks prior to randomization.
    - Have primary or secondary immunodeficiency syndromes, opportunistic infection, or infection with HIV, HBV, HCV or tuberculosis (active or latent):.
    - Have a clinically relevant cardiovascular condition or receiving treatments that may effect cardiovascular function
    - Have active retinopathy or macular oedema.
    - Have forced expiratory volume at 1 second or forced vital capacity <70% of predicted values at Screening.
    - Lactating female who is breastfeeding.
    - Any acute illnesses or medical conditions including cognitive impairment and alcohol/drug abuse/dependence, or signs/symptoms suspicious for a serious disease that, in the Investigator's opinion, could put the subject at increased risk for safety event(s) or interfere with protocol-specified procedures or adherence with study treatment.
    - Anamnesi di risposta inadeguata (vale a dire, assenza di risposta primaria) ad agenti appartenenti a >=2 classi di farmaci biologici disponibili in commercio per il trattamento della MC (ad es., antagonisti di TNFa, antagonista dell’interleuchina 12/ 23 e antagonista del recettore dell’integrina).
    - Presenza di colite ulcerosa, colite indeterminata, colite microscopica, colite ischemica, colite da radiazioni, colite associata a malattia diverticolare, megacolon tossico o colite infettiva in fase attiva o positività al test della tossina di Clostridium difficile (C. difficile) allo screening.
    - Presenza di sindrome dell’intestino corto funzionale o post-operatoria o qualsiasi complicazione ad essa associata che potrebbe richiedere un intervento chirurgico o interferire con le valutazioni dell’efficacia
    - Precedente trattamento chirurgico per ascessi intra addominali <=8 settimane prima della randomizzazione o trattamento chirurgico per ascessi perianali <=4 settimane prima della randomizzazione.
    - Precedente resezione intestinale <=24 settimane prima della randomizzazione o altri interventi chirurgici intra addominali <=12 settimane prima della randomizzazione.
    - Presenza di ileostomia o colostomia.
    - Presenza di un’infezione grave che richiede antibiotici/farmaci EV <=4 settimane prima della randomizzazione
    - Presenza di sindromi da immunodeficienza primaria o secondaria, infezione opportunistica o infezione da HIV, HBV, HCV o tubercolosi (attiva o latente)
    - Presenza di una condizione cardiovascolare clinicamente rilevante o ricevere trattamenti che possono influire sulla funzione cardiovascolare
    - Presenza di retinopatia attiva o edema maculare
    - Presenza di volume espiratorio forzato a 1 secondo (FEV1) o capacità vitale forzata (FVC) <70% dei valori previsti allo screening
    - Soggetti di sesso femminile che allattano al seno
    - Qualsiasi malattia o condizione medica ivi compresi deficit cognitivi e abuso di/dipendenza da alcol/farmaci, o segni/sintomi per i quali si sospetti una grave malattia che, a giudizio dello sperimentatore, potrebbe esporre il soggetto a un maggior rischio di uno o più eventi di sicurezza o interferire con le procedure specificate nel protocollo o con l’aderenza al trattamento in studio.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects who achieve endoscopic response at Week 14
    Percentuale di soggetti che raggiungono la risposta endoscopica alla Settimana 14
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 14
    Settimana 14
    E.5.2Secondary end point(s)
    • Proportion of subjects who achieve clinical remission APSF at Week 14
    • Proportion of subjects who achieve CDAI < 150 by visit up to Week 14
    • Proportion of subjects who achieve clinical response CDAI by visit up to Week 14
    • Proportion of subjects who achieve clinical response APSF by visit up to Week 14
    • Proportion of subjects who achieve clinical response CDAI-70 by visit up to Week 14
    • Proportion of subjects who achieve clinical response APSF-30 by visit up to Week 14
    • Change from baseline in CDAI score by visit up to Week 14
    • Change from baseline in SES-CD at Week 14
    • Proportion of subjects with clinical response by PRO2 at Week 14
    • Proportion of subjects with endoscopic response and clinical remission by PRO2 at Week 14
    • Change and percentage change from baseline in absolute lymphocyte count by visit up to Week 14
    • Change and percentage change from baseline in FCP concentration at Weeks 2, 4, 6, 10, and 14
    • Change and percentage change from baseline in CRP concentration at Weeks 2, 4, 6, 10, and 14
    • Proportion of subjects who achieve endoscopic remission at Week 14
    Extension Period:
    endpoints for the induction period will be assessed at scheduled visits up to Week 66.
    • Percentuale di soggetti che raggiungono la remissione clinica APSF alla Settimana 14
    • Percentuale di soggetti che raggiungono un CDAI <150 per visita fino alla Settimana 14
    • Percentuale di soggetti che raggiungono la risposta clinica CDAI per visita fino alla Settimana 14
    • Percentuale di soggetti che raggiungono la risposta clinica APSF per visita fino alla Settimana 14
    • Percentuale di soggetti che raggiungono la risposta clinica CDAI-70 per visita fino alla Settimana 14
    • Percentuale di soggetti che raggiungono la risposta clinica APSF-30 per visita fino alla Settimana 14
    • Variazione rispetto al basale nel punteggio CDAI per visita fino alla Settimana 14
    • Variazione rispetto al basale nel SES-CD alla Settimana 14
    • Percentuale di soggetti con risposta clinica in base agli esiti riferiti dal paziente (PRO2) alla Settimana 14
    • Percentuale di soggetti con risposta endoscopica e remissione clinica in base ai PRO2 alla Settimana 14
    • Variazione e variazione percentuale rispetto al basale nella conta assoluta dei linfociti per visita fino alla Settimana 14
    • Variazione e variazione percentuale rispetto al basale nella concentrazione di FCP alle Settimane 2, 4, 6, 10 e 14
    • Variazione e variazione percentuale rispetto al basale nella concentrazione di CRP alle Settimane 2, 4, 6, 10 e 14
    • Percentuale di soggetti che raggiungono la remissione endoscopica alla Settimana 14
    Endpoint del periodo di estensione:
    Gli endpoint per il Periodo di induzione saranno valutati in occasione delle visite programmate fino alla Settimana 66
    E.5.2.1Timepoint(s) of evaluation of this end point
    by visit up to week 66
    per visita fino alla Settimana 66
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    dose finding
    dose finding
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 trial3
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA214
    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
    Argentina
    Australia
    Belarus
    Brazil
    Canada
    Chile
    China
    Colombia
    Egypt
    Georgia
    India
    Israel
    Japan
    Korea, Republic of
    Lebanon
    Mexico
    Moldova, Republic of
    Peru
    Puerto Rico
    Russian Federation
    Serbia
    South Africa
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    Belgium
    Bulgaria
    Croatia
    Czechia
    Denmark
    France
    Germany
    Hungary
    Italy
    Latvia
    Lithuania
    Norway
    Poland
    Portugal
    Romania
    Slovakia
    Slovenia
    Spain
    Sweden
    Switzerland
    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
    LPLV
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years2
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 225
    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
    NESSUNO
    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 Decision2020-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-16
    P. End of Trial
    P.End of Trial StatusCompleted
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