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    Summary
    EudraCT Number:2011-004361-32
    Sponsor's Protocol Code Number:KKS-166
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-22
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-004361-32
    A.3Full title of the trial
    Effect of simvastatin in combination with a superpotent topical corticosteroid in bullous pemphigoid

    A prospective multi-centre randomised double-blind placebo-controlled
    pilot study
    Wirksamkeit von Simvastatin in Kombination mit hochpotenten topischen Kortikosteroiden bei der Behandlung des bullösen Pemphigoids

    Prospektive, multizentrische, randomisierte, doppelblinde, placebo-kontrollierte Pilotstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of simvastatin in combination with a superpotent topical corticosteroid in bullous pemphigoid
    Wirksamkeit von Simvastatin in Kombination mit hochpotenten topischen Kortikosteroiden bei der Behandlung des bullösen Pemphigoids
    A.3.2Name or abbreviated title of the trial where available
    SICOPEM
    A.4.1Sponsor's protocol code numberKKS-166
    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 SponsorPhilipps-Universität Marburg
    B.1.3.4CountryGermany
    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 supportUniversitätsklinikum Marburg-Klinik für Dermatologie
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportUniversitätsklinikum Würzburg-Klinik für Dermatologie
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPhilipps-Universität Marburg
    B.5.2Functional name of contact pointKoordinierungszentrum für Klinische
    B.5.3 Address:
    B.5.3.1Street AddressKarl-von-Frisch-Str. 4
    B.5.3.2Town/ cityMarburg
    B.5.3.3Post codeD-35043
    B.5.3.4CountryGermany
    B.5.4Telephone number004964212866509
    B.5.5Fax number004964212866517
    B.5.6E-mailkarin.weide@kks.uni-marburg.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Simvastatin-ratiopharm®
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSimvastatin-ratiopharm
    D.3.4Pharmaceutical form Capsule
    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.3.9.1CAS number 79902-63-9
    D.3.9.3Other descriptive nameSIMVASTATIN
    D.3.9.4EV Substance CodeSUB10529MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboCapsule
    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
    Bullous pemphigoid (BP) is the most frequent blistering autoimmune disease of the skin. The disease itself is characterized by the development of bullous lesions, frequently following a prodromal phase with severe itching. Between 10 to 30 percent of patients exhibit mucosal membrane involvement in addition to the skin lesions.

    Das Bullöse Pemphigoid ist die am häufigsten auftretende blasenbildende Autoimmunerkrankung der Haut. Die Krankheit ist charakterisiert durch die Bildung von blasigen Läsionen, häufig folgend auf eine prodromale Phase mit starkem Juckreiz. Bei zwischen 10-30 Prozent der Patienten ist zusätzlich zu den Hautläsionen auch die Schleimhaut betroffen.
    E.1.1.1Medical condition in easily understood language
    Bullous pemphigoid (BP) is the most frequent blistering autoimmune disease of the skin.
    Das Bullöse Pemphigoid (BP) ist die am häufigsten auftretende blasenbildende Autoimmunerkrankung der Haut.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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 aim of the pilot study is to gather data about recruitment potential, compliance to the interventional treatment, and adherence to planned study visits in order to decide about the feasibility of a phase III trial that will investigate, whether the relapse-free interval of patients suffering from bullous pemphigoid and treated with high-potent topical corticosteroids can be prolonged by additional oral application of simvastatin 40 mg daily.
    Ziel der Pilotstudie ist das Sammeln von Daten zum Rekrutierungspotential, der Compliance der Patienten bezüglich der Behandlung und der Teilnahme an den geplanten Studienvisiten. An Hand dieser Daten soll über die Feasibility einer Phase-III-Studie entschieden werden, die die Frage klären soll, ob eine zusätzliche orale Gabe von Simvastatin (40 mg pro Tag) bei Patienten mit bullösem Pemphigoid, die mit hochpotenten topischen Glukokortikoiden behandelt werden, zu einer Verlängerung des rezidivfreien Intervalls führt.
    E.2.2Secondary objectives of the trial
    Secondary endpoints see below
    Sekundäre Endpunkte siehe unten
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with newly diagnosed or relapsing bullous or pruriginous pemphigoid:
    The diagnosis is based on clinical symptoms typical for active bullous or pruriginous pemphigoid: blisters, urticarial plaques, pruriginous papules or eczematous skin alterations.
    The clinical extent of BP at screening must exceed values for BPDAI of ≥ 15 (15 or more of max. 240 without damage) or modified ABSIS of ≥ 5 (5 or more of max. 150).
    Newly diagnosed patients only:
    positive direct immunofluorescence (DIF) with linear deposition of IgG and/or C3 at the dermo-epidermal basal membrane zone
    All patients:
    1. optional: skin biopsy (histological evidence for subepidermal blister formation)
    2. IgG reactivity with blister roof of saline-split human skin using indirect immunofluorescence and IgG reactivity against BP180 and/or BP230 by ELISA
    • Male and female patients aged ≥55 years
    • Only confirmed postmenopausal female patients, whose last menorrhoea occurred more than 1 year ago.
    • Patients with newly diagnosed or relapsing bullous or pruriginous pemphigoid
    The diagnosis is based on clinical symptoms typical for active bullous or pruriginous pemphigoid.
    • Age ≥ 55 years
    • Written informed consent by patient or written informed consent of the patient’s legal representative
    • Karnofsky-Index ≥ 30%

    • Patienten mit klinischen Zeichen eines aktiven bullösen oder pruriginösen Pemphigoids (Neudiagnose oder Rezidiv). Die Diagnose basiert auf klinischen Symptomen des aktiven bullösen oder pruriginösen Pemphigoid: Blasen, urtikarielle Plaques, pruriginöse Papeln oder ekzematöse Hautveränderungen.
    Die klinische Ausdehnung des BP bei Screening muss folgende Werte übersteigen BPDAI ≥ 15 (15 oder mehr von max. 240 ohne damage) oder modified ABSIS ≥ 5 (5 oder mehr von max. 150).
    Nur Neudiagnosen:
    Positive direkte Immunfluoreszenz (DIF) mit linearer Ablagerung von IgG und/oder C3 an der dermo-epidermalen Basalmembran
    Alle Patienten:
    1. optional: Hautbiopsie (histologischer Nachweis für subepidermale Blasenbildung)
    2. IgG Reaktivität mit humaner Kochsalzspalthaut mittels indirekter Immunfluoreszenz und IgG Reaktivität gegen BP180 und/oder BP230 mittels ELISA
    • Männliche und weibliche Patienten Alter ≥55 Jahre
    • Nur gesichert postmenopausale Patientinnen, bei denen länger als 1 Jahr keine Menstruationsblutung mehr aufgetreten ist.
    • Unterzeichnete schriftliche Einverständniserklärung des Patienten oder seines gesetzlichen Vertreters
    • Karnofsky-Index ≥ 30%
    E.4Principal exclusion criteria
    • Predominant or exclusive mucosal involvement
    • Treatment with systemic corticosteroids >10mg prednisolone equivalent if systemic corticosteroids cannot be completely tapered until study visit 1
    • Treatment with systemic corticosteroids ≤ 10mg prednisolone equivalent for a time period less than four weeks prior to randomisation
    • Hypersensitivity to Simvastatin or other ingredients of the IMPs
    • Treatment with topical calcineurin inhibitors, dapsone, immunosuppressive drugs (azathioprine, mycofenolate mofetil, cyclophosphamide, methotrexate, ciclosporin) or tetracyclines within the past month prior to randomisation
    • Treatment with intravenous immunoglobulins, immunoadsorption or TNF-alpha antagonists within the past 3 months prior to randomisation
    • Treatment with rituximab or leflunomide within the past 12 months prior to randomisation
    • Concurrent treatment with potent CYP3A4-inhibitors (itraconazole, ketoconazole, fluconazole, posaconazole, HIV protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin, nefazodon)
    • Concurrent treatment with less potent CYP3A4-inhibitors (verapamil, diltiazem, voriconazol, danazol, fibrates, niacin, amiodarone, gemfibrozil, fusidic acid, consumption of grapefruit juice)
    • Treatment with simvastatin or other statins four weeks prior to randomisation
    • Chronic muscle diseases or increase of creatine kinase above 2.5fold of normal value
    • Hereditary muscle diseases in medical history
    • Contact hypersensitivity to clobetasol
    • Renal dysfunction (creatinine clearance<30ml/min according to the Cockcroft and Gault Formula (30))
    • Untreated hypothyreosis
    • Active liver disease or prolonged increased transaminase levels >3x upper limit of normal and increased total bilirubin>3mg/dl
    • Alcohol dependency
    • poorly controlled diabetes mellitus (glycohaemoglobin > 8,0 %)
    • Inability to apply topical glucocorticoids and to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations
    • Illiteracy or insufficient language skills (German) to complete the questionnaires
    • Simultaneous participation in another clinical trial except if that other trial does not affect the study as approved and documented by the principal investigators
    • Überwiegende oder ausschließliche Schleimhautbeteiligung
    • Behandlung mit systemischen Kortikosteroiden > 10mg Prednisolon Äquivalent, wenn die systemischen Kortikosteroide nicht bis Studienvisit 1 vollständig abgesetzt werden können
    • Behandlung mit systemischen Kortikosteroiden ≤ 10 mg Prednisolon Äquivalent über einen Zeitraum von weniger als 4 Wochen vor Randomisation
    • Überempfindlichkeit gegenüber Simvastatin oder anderen Bestandteilen der IMPs
    • Vorangegangene Therapie mit topischen Calcineurininhibitoren, Dapson, Immun-suppressiva (Azathioprin, Mycophenolatmofetil, Cyclophosphamid, Methotrexat, Ciclosporin) oder Tetrazyklinen 4 Wochen vor Einschluss in die Studie
    • Vorangegangene Therapie mit intravenösen Immunglobulinen, Immunadsorption oder TNF-alpha Antagonisten während der letzten 3 Monate vor Einschluss in die Studie
    • Vorangegangene Therapie mit Rituximab oder Leflunomid während der letzten 12 Monate vor Einschluss in die Studie
    • Aktuelle Therapie mit potenten CYP3A4-Inhibitoren (Itraconazol, Ketoconazol, Fluconazol, Posaconazol, HIV-Protease-Inhibitoren (z.B. Nelfinavir), Erythromycin, Clarithromycin, Telithromycin, Nefazodon)
    • Aktuelle Therapie mit weniger potenten CYP3A4-inhibitors (Verapamil, Diltiazem, Voriconazol, Danazol, Fibrate, Niacin, Amiodaron, Gemfibrozil, Fusidinsäure, Verzehr von Grapefruitsaft)
    • Behandlung mit Simvastatin oder anderen Statinen während der letzten 4 Wochen vor Randomisation
    • Chronische Muskelerkrankungen oder eine Erhöhung der Kreatinkinase auf das über 2,5-fache des Normwerts
    • Hereditäre Muskelerkrankungen in der Anamnese
    • Bekannte Überempfindlichkeit gegenüber Clobetasol
    • Niereninsuffizienz (Kreatininclearance <30ml/min entsprechend der Cockcroft und Gault Formel (30) )
    • Unbehandelte Hypothyreose
    • Aktive Lebererkrankungen oder dauerhaft erhöhte Transaminasewerte >3x der oberen Grenze des Normalwertes und erhöhtes Gesamtbilirubin > 3mg/dl
    • Alkoholabhängigkeit
    • Schlecht eingestellter Diabetes mellitus (HbA1c > 8,0 %)
    • Unfähigkeit, topische Kortikosteroide zu applizieren und mangelnde Compliance
    • Analphabetismus oder ungenügende Deutschkenntnisse zum Ausfüllen der Fragebögen
    • Gleichzeitige Teilnahme an einer anderen Studie, wenn diese die Teilnahme an der Studie beeinflusst
    E.5 End points
    E.5.1Primary end point(s)
    Feasibility criteria:
    • Yearly accrual rate
    • Proportion of patients compliant with interventional treatment
    • Proportion of patients adhering to planned study visits
    Feasibility Kriterien:
    • Jährliche Rekrutierungsrate
    • Anteil der Patienten, die compliant bezüglich der Studienbehandlung sind
    • Anteil der Patienten, die an den geplanten Studienvisiten teilnehmen
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1 (day 0), Visit 2 (day 10), Visit 3 (day 30), Visit 4 (day 90), Visit 5 (day 120), Visit 6 (day 180), Visit 7 (day 270), Visit 8 (day 360)
    Visit 1 (Tag 0), Visit 2 (Tag 10), Visit 3 (Tag 30), Visit 4 (Tag 90), Visit 5 (Tag 120), Visit 6 (Tag 180), Visit 7 (Tag 270), Visit 8 (Tag 360)
    E.5.2Secondary end point(s)
    • Relapse-free survival (RFS) defined as the time interval from randomisation to relapse or death of the patient (This is the designated primary efficacy endpoint of the phase III trial).
    • Time to control of disease activity (defined as the time interval from randomisation to the time at which new lesions cease to form and established lesions begin to heal or pruritic symptoms start to abate)
    • Time to complete remission on minimal therapy (defined as the absence of new or established lesions or pruritus while patient is receiving minimal therapy for at least 2 months)
    • Duration of complete remission on minimal therapy (defined as the time interval from complete remission on minimal therapy to relapse)
    Clinical endpoints:
    • Cumulative dose of clobetasol cream
    • Change in clinical severity scores (modified ABSIS – Autoimmune bullous skin disorder intensity score, BPDAI – Bullous Pemphigoid Disease Activity Index)
    • Change in life quality questionnaires (EQ-5D, DLQI, GDS)
    • Serum concentration of autoantibodies during follow-up
    • Serum concentration of pro- and anti-inflammatory cytokines and other parameters during follow-up
    • Rezidivfreies Überleben definiert als Zeitintervall von der Randomisierung bis zum Auftreten eines Rezidivs oder dem Tod des Patienten (dies ist das vorgesehene primäre Zielkriterium einer späteren Phase III Studie)
    • Dauer bis zur Krankheitskontrolle (definiert als der Zeitpunkt, an dem keine neuen Läsionen mehr auftreten, bestehende Läsionen zu heilen beginnen oder Juckreiz beginnt abzunehmen)
    • Dauer bis zum Erreichen der klinischen Remission (definiert als Abwesenheit neuer oder alter Läsionen und des Juckreizes für mindestens 2 Monate unter Minimaltherapie)
    • Dauer der klinischen Remission (definiert als Zeitintervall von der klinischen Remission bis zum Rezidiv unter Minimaltherapie)
    Klinische Endpunkte:
    • Kumulative Dosis der Clobetasol Creme
    • Änderungen der klinischen Scores (modifizierter ABSIS – Autoimmune bullous skin disorder intensity score, BPDAI – Pemphigus Disease Area Index)
    • Änderungen der Lebensqualitätsscores (EQ-5D, DLQI, GDS )
    • Serumkonzentration der Autoantikörper während des Follow-ups
    • Serumkonzentration pro- und antiinflammatorischer Zytokine und weiterer Parameter während des Follow-ups
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1 (day 0), Visit 2 (day 10), Visit 3 (day 30), Visit 4 (day 90), Visit 5 (day 120), Visit 6 (day 180), Visit 7 (day 270), Visit 8 (day 360)
    Visit 1 (Tag 0), Visit 2 (Tag 10), Visit 3 (Tag 30), Visit 4 (Tag 90), Visit 5 (Tag 120), Visit 6 (Tag 180), Visit 7 (Tag 270), Visit 8 (Tag 360)
    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 No
    E.6.5Efficacy No
    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) 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 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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last subject undergoing the trial and data base closure
    Letzte Visite des letzten Studienpatienten und Datenbankschluss
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 30
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    Patients with a symptom-free skin finding do not receive further treatment, but will come to consultations at regular intervals. Patients with a relapse of bullous pemphigoid are treated with a topical corticosteroid according to standard therapy.
    Patienten mit blandem, erscheinungsfreiem Hautbefund erhalten keine weitere Behandlung, werden aber in regelmäßigen Abständen in der Autoimmunsprechstunde gesehen. Patienten mit einem Rezidiv des bullösen Pemphigoids werden gemäß der Standardtherapie mit topischen Steroiden behandelt.
    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 Decision2013-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-02-02
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