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    Summary
    EudraCT Number:2011-000603-40
    Sponsor's Protocol Code Number:FER-CARS-04
    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:2012-01-23
    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 number2011-000603-40
    A.3Full title of the trial
    Multicentre, prospective, randomised, 2-arm study to assess the impact of ferric carboxymaltose on exercise capacity in chronic heart failure patients with iron deficiency
    Studio multicentrico, prospettico, randomizzato, a 2 bracci per valutare l'impatto del carbossimaltosio ferrico sulla capacita' di esercizio fisico nei pazienti affetti da insufficienza cardiaca cronica con carenza di ferro.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFfect of Ferric carboxymaltose on Exercise Capacity in paTients with iron deficiency and chronic Heart Failure
    effetto del carbossimaltosio ferrico sulla capacita' di esercizio fisico nei pazienti con carenza di ferro e insufficienza cardiaca cronica
    A.3.2Name or abbreviated title of the trial where available
    EFFECT-HF
    EFFECT-HF
    A.4.1Sponsor's protocol code numberFER-CARS-04
    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 SponsorVIFOR (INTERNATIONAL) INC.
    B.1.3.4CountrySwitzerland
    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 supportVifor (International) Inc.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVifor (International) Inc.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressFlughofstrasse 61
    B.5.3.2Town/ cityGlattbrugg
    B.5.3.3Post codeCH-8152
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+ 41 58 851 8222
    B.5.5Fax number+ 41 58 851 8002
    B.5.6E-mailmedinfo@viforpharma.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.2.1.1.1Trade name Ferinject
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France SA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFERRIC CARBOXYMALTOSE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Iron deficiency in patients with chronic heart failure
    carenza di ferro in pazienti con insufficienza cardiaca cronica
    E.1.1.1Medical condition in easily understood language
    Iron deficiency in patients with chronic heart failure
    carenza di ferro in pazienti con insufficienza cardiaca cronica
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10022970
    E.1.2Term Iron deficiency
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    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 efficacy of intravenous (IV) FCM compared to usual care on exercise capacity.
    Valutare l'efficacia del carbossimaltosio ferrico per via endovenosa (EV) rispetto alla terapia comune sulla capacità di esercizio fisico.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of IV FCM compared to usual care on biomarkers for iron deficiency (ID), cardiac biomarkers, New York Heart Association (NYHA) functional class, patient global assessment (PGA), quality of life (QoL), renal function, cardiac function as assessed by echocardiography (ECHO) and iron requirements in iron-deficient CHF subjects. • To evaluate the safety of IV FCM over the treatment period.
    • Valutare l'efficacia del carbossimaltosio ferrico EV rispetto alla terapia comune su biomarcatori per la carenza di ferro, biomarcatori di cardiopatia, classe funzionale NYHA (New York Heart Association), valutazione globale del paziente, qualità della vita, funzionalità renale, funzione cardiaca valutata dall'ecocardiografia e fabbisogno di ferro nei soggetti affetti da insufficienza cardiaca cronica con carenza di ferro. • Valutare la sicurezza del carbossimaltosio ferrico EV durante il periodo di trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects with stable CHF (NYHA II-III functional class) on optimal background therapy (as determined by the Investigator) for at least 4 weeks with no dose changes of heart failure drugs during the last 2 weeks (with the exception of diuretics). In general, optimal pharmacological treatment should include a diuretic, a beta-blocker, and/or an angiotensin converting enzyme inhibitor or angiotensin II receptor blocker unless contraindicated or not tolerated. 2. Left ventricular ejection fraction ≤45% (value within 3 months of planned date of randomisation). 3. Exercise limitation as evidenced by reproducible peak VO2 10 18 mL/kg/min during screening. This will be estimated by 2 tests (completed within 4 weeks of each other and at least 3 days between each other) with at least 1 test completed within 4 weeks before baseline visit. Historical peak VO2 test can be used as Test 1 if performed within 4 weeks before screening. The 2 tests must have less than 10% difference in values. If more than 10%, a third test may be performed within 4 weeks and at least 3 days after Test 2. For the baseline test, the respiratory exchange ratio (RER) ≥1.0. 4. Brain natriuretic peptide (BNP) >100 pg/mL and/or N terminal pro BNP (NT-proBNP) >400 pg/mL. 5. Screening ferritin <100 ng/mL OR ferritin 100-300 ng/mL with TSAT <20%. 6. At least 18 years of age. 7. Before any study-specific procedure, the appropriate written informed consent must be obtained.
    1. Soggetti con insufficienza cardiaca cronica stabile (classe funzionale II-III NYHA) che seguono una terapia di base ottimale (come stabilito dallo sperimentatore) da almeno 4 settimane senza variazioni del dosaggio dei farmaci per l'insufficienza cardiaca nelle ultime 2 settimane (ad eccezione dei diuretici). In generale, il trattamento farmacologico ottimale deve includere un diuretico, un betabloccante e/o un inibitore dell'enzima di conversione dell'angiotensina o un bloccante del recettore dell'angiotensina II se non controindicati o non tollerati. 2. Frazione di eiezione ventricolare sinistra ≤45% (valore entro 3 mesi dalla data pianificata della randomizzazione). 3. Limitazione dell'esercizio fisico come evidenziato dal picco riproducibile di VO2 10-18 ml/kg/min durante lo screening. Viene stimata da 2 test (completati entro 4 settimane l'uno dall'altro, con almeno 3 giorni di distanza tra l'uno e l'altro) con almeno 1 test completato 4 settimane prima della visita basale. Il test di cronologia di picco di VO2 può essere utilizzato come test 1 se eseguito 4 settimane prima dello screening. I 2 test devono presentare una differenza nei valori inferiore al 10%. Se la differenza è superiore al 10%, è possibile eseguire un terzo test entro 4 settimane e almeno 3 giorni dopo il test 2. Per il test basale, il rapporto di scambio respiratorio deve essere ≥1,0. 4. Peptide natriuretico cerebrale (BNP) &gt;100 pg/ml e/o pro BNP N-terminale (NT-proBNP) &gt;400 pg/ml. 5.Ferritina allo screening &lt;100 ng/ml OPPURE ferritina pari a 100-300 ng/ml con TSAT &lt;20%. 6. Almeno 18 anni di età. 7. Prima di qualsiasi procedura dello studio, è necessario ottenere il consenso informato scritto appropriato.
    E.4Principal exclusion criteria
    1. Subject has known sensitivity to any of the products to be administered during dosing. 1. History of acquired iron overload. 2. History of erythropoietin stimulating agent, IV iron therapy, and/or blood transfusion in previous 6 weeks prior to randomisation. 3. Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months. 4. Subject at an immediate need of transfusion or haemoglobin (Hb) >15 g/dL. 5. Known active bacterial infection. 6. Chronic liver disease and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range. 7. Vitamin B12 and/or serum folate deficiency. If deficiency corrected subject may be rescreened for inclusion. 8. Known human immunodeficiency virus/acquired immunodeficiency syndrome or active hepatitis B or C. 9. Clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia. 10. Currently receiving systemic chemotherapy and/or radiotherapy. 11. Renal dialysis (previous, current or planned within the next 6 months). 12. Unstable angina pectoris as judged by the Investigator; severe valvular or left ventricular outflow obstruction disease needing intervention; atrial fibrillation/flutter with a mean ventricular response rate at rest >100 beats per minute. 13. Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months prior to randomisation. 14. Coronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomisation. 15. Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study (ies), or subject is receiving other investigational agent(s). 16. Subject of child-bearing potential who is pregnant (e.g., positive human chorionic gonadotropin test) or is breast feeding. 17. Subject is not using adequate contraceptive precautions during the study and for up to 5 days after the last dose of the study medication. 18. Subject previously randomised to this study. Note: Subjects may be rescreened if they fail any of the screening procedures. If rescreened, all tests must fall inside the maximum specified screening windows for each criterion. 19. Subject will not be available for all protocol specified assessments. 20. Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
    1. Il soggetto presenta una sensibilità nota ai prodotti da somministrare durante il trattamento. 2. Anamnesi di sovraccarico di ferro acquisito. 3. Anamnesi di agente stimolante dell'eritropoietina, terapia endovenosa con ferro e/o trasfusione di sangue nelle 6 settimane precedenti alla randomizzazione. 4. Programmi di esercizio fisico nei 3 mesi precedenti allo screening o pianificati nei 6 mesi successivi. 5. Il soggetto ha necessità immediata di trasfusione o emoglobina (Hb) &gt;15 g/dl. 6. Infezione batterica attiva nota. 7. Epatopatia cronica e/o alanina transaminasi o aspartato transaminasi allo screening pari a 3 volte il limite superiore dell'intervallo normale. 8. Carenza di vitamina B12 e/o di folati nel siero. Se la carenza viene corretta, il soggetto può essere sottoposto a un altro screening per l'inclusione. 9. Virus dell'immunodeficienza umana/sindrome da immunodeficienza acquisita noti o epatite B o C attiva. 10. Evidenza clinica di patologia maligna corrente, ad eccezione del carcinoma basocellulare o spinocellulare della cute e della neoplasia intraepiteliale della cervice. 11. Chemioterapia e/o radioterapia sistemiche in corso. 12. Dialisi renale (precedente, attuale o pianificata nei 6 mesi successivi). 13. Angina pectoris instabile come valutata dallo sperimentatore; patologia grave di ostruzione dell'efflusso ventricolare sinistro o valvolare che necessita di intervento; fibrillazione/flutter atriale con un tasso di risposta ventricolare medio a riposo &gt;100 battiti al minuto. 14. Infarto miocardico acuto o sindrome coronarica acuta, attacco ischemico transitorio o ictus nei 3 mesi precedenti alla randomizzazione. 15. Innesto di bypass di arteria coronaria, intervento percutaneo (ad es. cardiaco, cerebrovascolare, aortico; sono consentiti i cateteri diagnostici) o intervento chirurgico importante, incluse chirurgia toracica e cardiaca entro i 3 mesi precedenti alla randomizzazione. 16. Il soggetto è attualmente arruolato o non sono ancora trascorsi 30 giorni dalla fine di altri studi su dispositivi o farmaci sperimentali o al soggetto vengono somministrati altri agenti sperimentali. 17. Il soggetto è in stato di gravidanza (ad es. positività al test della gonadotropina corionica umana) o in allattamento. 18. Il soggetto non utilizza adeguate precauzioni contraccettive durante lo studio e per almeno 5 giorni dopo l'ultima dose di farmaco dello studio. 19. Il soggetto è stato randomizzato in precedenza per questo studio. Nota: i soggetti possono essere sottoposti a un altro screening se non superano una qualsiasi delle procedure di screening. Se sottoposti nuovamente a screening, tutti i test devono rientrare nelle finestre di screening massime specificate per ciascun criterio. 20. Il soggetto non è disponibile per tutti gli esami del protocollo specificati. 21. Il soggetto presenta disturbi che compromettono la sua capacità di fornire il consenso informato scritto e/o rispettare le procedure dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    • Change in peak VO2 (mL/kg/min) from baseline to Week 24
    • Variazione del picco di VO2 (ml/kg/min) rispetto al basale alla settimana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    settimana 24
    E.5.2Secondary end point(s)
    • Change in peak VO2 (mL/kg/min) from baseline to Week 12 • Change in minute ventilation-carbon dioxide production slope from baseline to Weeks 12 and 24 • Changes from baseline to Weeks 6, 12 and 24 in:  Key laboratory and iron parameters  Cardiac biomarkers (including BNP and NT-proBNP)  NYHA  PGA  QoL (Kansas City cardiomyopathy questionnaire (KCCQ) and European quality of life 5D questionnaire (EQ 5D)) • Changes from baseline to Weeks 12 and 24 in ECHO measurements:  Left ventricular ejection fraction (%)  Left ventricular end systolic and diastolic diameters (mm)  Interventricular and posterior wall thickness (mm)  Left atrial diameter (mm; parasternal long axis view)  Mitral valve regurgitation (moderate - severe)  E-wave velocity to A-wave velocity ratio  Tissue early velocity (E’ in cm/s from septal and lateral wall) • Cumulative iron requirements and number of iron administrations over the study period • Percentage of subjects meeting key safety endpoint defined as time to:  Death  (First) hospitalisation for worsening heart failure  Heart transplantation
    • Variazione del picco di VO2 (ml/kg/min) rispetto al basale alla settimana 12 • Variazione della pendenza del grafico ventilazione al minuto-produzione di anidride carbonica rispetto al basale alle settimane 12 e 24 • Variazioni rispetto al basale alle settimane 6, 12 e 24 per:  Parametri di laboratorio principali e del ferro  Biomarcatori di cardiopatia (inclusi BNP e NT-proBNP)  NYHA  Valutazione globale del paziente  Qualità della vita [Kansas City Cardiomyopathy Questionnaire (KCCQ) e Questionario europeo sulla Qualità della vita 5D (EQ 5D)] • Variazioni rispetto al basale alle settimane 12 e 24 delle misurazioni ECHO:  Frazione di eiezione ventricolare sinistra (%)  Diametri telesistolico e telediastolico ventricolari sinistri (mm)  Spessore del setto interventricolare e della parete posteriore (mm)  Diametro atriale sinistro (mm; vista asse lungo parasternale)  Rigurgito della valvola mitrale (moderato - grave)  Rapporto velocità onda E/velocità onda A  Velocità precoce tessuto (E' in cm/s dal setto e dalla parete laterale) • Fabbisogno di ferro cumulativo e numero di somministrazioni di ferro durante lo studio • Percentuale di soggetti che soddisfano l'endpoint di sicurezza principale definito come il tempo al:  Decesso  (Primo) ricovero ospedaliero per peggioramento dell'insufficienza cardiaca  Trapianto cardiaco
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 12 2. Week 12 & Week 24 3. Week 6, Week 12, & Week 24 4. End of Study 5. End of Study
    1. Settimana 12 2. Settimana 12 & Settimana 24 3. Settimana 6, Settimana 12, & Settimana 24 4. Termine dello studio 5. Termine dello studio
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Terapia standard. Ferro IV non consentito
    Standard of care. IV iron not permitted
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Australia
    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 years0
    E.8.9.1In the Member State concerned months29
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months29
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 96
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 137
    F.4.2.2In the whole clinical trial 160
    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)
    Should patients require additional iron post repletion and completion of the study, either Ferinject or alternative iron replacement therapies are available for use by treating physician
    Nel caso in cui i pazienti al termine dello studio dovessero richiedere o Ferinject o ferro alternativo terapie sostitutive sono disponibili per l'uso da parte del medico che ha in cura il paziente
    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 Decision2011-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-18
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