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    Summary
    EudraCT Number:2011-003719-42
    Sponsor's Protocol Code Number:GO27821
    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:2012-04-02
    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 number2011-003719-42
    A.3Full title of the trial
    A RANDOMIZED, PHASE II, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF MetMAb IN COMBINATION WITH EITHER BEVACIZUMAB + PLATINUM + PACLITAXEL OR PEMETREXED + PLATINUM AS FIRST-LINE TREATMENT IN PATIENTS WITH STAGE IIIB or IV NON-SQUAMOUS NON−SMALL CELL LUNG CANCER (NSCLC)
    STUDIO DI FASE II, RANDOMIZZATO, MULTICENTRICO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO, PER VALUTARE L'EFFICACIA E LA SICUREZZA DI MetMAb IN COMBINAZIONE CON BEVACIZUMAB + PLATINO + PACLITAXEL O PEMETREXED + PLATINO COME TRATTAMENTO IN PRIMA LINEA DI PAZIENTI CON CANCRO POLMONARE NON A PICCOLE CELLULE (NSCLC) NON SQUAMOSO DI STADIO IIIB o IV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and the safety of MetMAb in combination
    with either bevacizumab + platinum + paclitaxel or pemetrexed +
    platinum in lung cancer patients (non-squamous non-small cell lung
    cancer).
    Studi per valutare l'efficacia e la sicurezza di MetMab in combinazione con bevacizumab + platinum + paclitaxel o pemetrexed +
    platinum in pazienti con cancro polmonare non a piccole cellule
    A.4.1Sponsor's protocol code numberGO27821
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    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 supportGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoche SpA
    B.5.2Functional name of contact pointCountry Head Clin. Ops. Italy
    B.5.3 Address:
    B.5.3.1Street AddressViale G.B. Stucchi, 110
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number039 2475070
    B.5.5Fax number039 2475084
    B.5.6E-mailsergio.scaccabarozzi@roche.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 nameMetMab
    D.3.2Product code Ro 549-0258/F01-01
    D.3.4Pharmaceutical form Solution for infusion
    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 INNonartuzumab
    D.3.9.1CAS number 1133766-06-9
    D.3.9.2Current sponsor codeRO5490258/PRO143966
    D.3.9.3Other descriptive nameOne Armed anti-cMet, OA5D5, c-Met, Anti-Met
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    MET DIAGNOSTIC−POSITIVE NON−SMALL CELL LUNG CANCER (NSCLC)
    CANCRO POLMONARE NON A PICCOLE CELLULE (NSCLC) SQUAMOSO DI STADIO IIIB (PATOLOGIA T4) O IV
    E.1.1.1Medical condition in easily understood language
    Incurable lung cancer (NSCLC)
    Cancro polmonare non curabile
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025048
    E.1.2Term Lung cancer non-small cell recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 MetMAb compared with placebo by PFS in
    all patients and in the subgroup of patients with Met diagnostic–positive
    tumors in each of two combination treatment cohorts:
    Cohort 1: MetMAb + bevacizumab + platinum + paclitaxel vs. placebo +
    bevacizumab + platinum + paclitaxel
    Cohort 2: MetMAb + platinum + pemetrexed vs. placebo + platinum +
    pemetrexed
    Valutare l'efficacia di MetMAb rispetto al placebo nei pazienti con NSCLC non squamoso nel trattamento di prima linea, espressa come sopravvivenza libera da progressione (PFS) valutata dallo Sperimentatore nella popolazione (non selezionata) intent-to-treat (ITT) in ciascuna delle
    due coorti di trattamento combinato:
    Trattamento Avastin (Coorte 1): MetMAb + bevacizumab + platino + paclitaxel vs.
    placebo + bevacizumab + platino + paclitaxel
    Trattamento non Avastin (Coorte 2): MetMAb + platino + pemetrexed vs.
    placebo + platino + pemetrexed
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy of MetMAb compared with placebo, as
    measured by OS, in each treatment cohort, in all patients and in those
    who have Met diagnostic–positive NSCLC
    -To evaluate the efficacy of MetMAb compared with placebo, as
    measured by overall response rate (ORR), duration of response (DOR),
    and disease control rate (DCR), in each treatment cohort, in all patients
    and in those who have Met diagnostic–positive NSCLC
    • To evaluate the safety and tolerability of MetMAb compared with
    placebo
    • To describe the pharmacokinetics (PK) of MetMAb given in combination
    with bevacizumab, platinum, and paclitaxel or pemetrexed
    • To evaluate the possible effect of MetMAb on the PK of bevacizumab,
    platinum, paclitaxel, and pemetrexed
    • To evaluate potential immune responses against MetMAb
    -valutare l'efficacia di MetMab rispetto a placebo, misurata come OS, in entrambe le coorti di trattamento, sia per la popolazione ITT, sia per quella Met-positiva
    -valutare la sicurezza e la tollerabilità di MetMab rispetto al placebo
    -descrivere la farmacocinetica di Metmab in combinazione con Bevacizumab, platine e paclitaxel o pemetrexed
    -valutare il possibile effetto di MetMab sulla farmacocinetica di Bevacizumab, platino, paclitaxel e pemetrexed
    -Valutare i livelli nel siero e l'incidenza di ATA rispetto a MetMAb
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent
    • Male or female, 18 years of age or older
    • ECOG performance status of 0 or 1
    • Stage IIIB or Stage IV NSCLC tumors of non-squamous histology
    (Stage IIIB eligible only if stage T4 disease not amenable to definitive
    surgery or radiation therapy)
    • For patients who received prior adjuvant chemotherapy:
    a treatment free interval of at least 12 months since the last
    chemotherapy cycle
    • Adequate tissue for central IHC assay of Met receptor, and EGFR
    testing if EGFR status is unknown
    • Adequate hematologic, hepatic, and renal function
    • Adequate contraception, during the treatment period and for at least
    90 days after the last dose of study drug, if applicable.
    -Capacità e volontà di fornire un consenso informato scritto e conformarsi al protocollo dello
    studio
    -Sesso maschile o femminile ed età ≥ 18 anni
    -Stato di performance ECOG 0 o 1
    -Tumori NSCLC di istologia non squamosa di Stadio IIIB o IV confermati istologicamente o
    citologicamente
    I pazienti con NSCLC di Stadio IIIB sono idonei solo se la loro patologia è classificata
    come T4 e non può essere curata con chirurgia definitiva o radioterapia.
    -Per i pazienti che hanno ricevuto una precedente chemioterapia adiuvante: un intervallo senza chemioterapia di almeno 12 mesi dall'ultimo ciclo
    -Tessuto adeguato per test immunoistochimico centrale del recettore Met e test EGFR se lo
    stato EGFR non è noto
    -Evidenza radiografica della patologia (una patologia misurabile è da preferire, ma non obbligatoria)
    -Per le donne non in stato di post-menopausa (12 mesi di amenorrea) o non sterili in seguito a intervento chirurgico (assenza di ovaie e/o utero): accordo a utilizzare un metodo contraccettivo adeguato durante il periodo di trattamento e per almeno 90 giorni dopo l’ultima dose di farmaco
    dello studio
    -Per i pazienti di sesso maschile la cui compagna è in pre-menopausa: accordo a utilizzare un metodo contraccettivo a barriera durante il periodo di trattamento e per almeno 90 giorni dopo l’ultima dose di farmaco dello studio
    E.4Principal exclusion criteria
    • Prior systemic treatment for Stage IIIB or IV non-squamous NSCLC
    • Mixed NSCLC histology with squamous cell predominance
    • Prior exposure to experimental treatment targeting either the HGF or
    Met pathway
    • Tumors confirmed to have EGFR activating mutations suitable for anti-
    EGFR therapy
    • Known central nervous system (CNS) disease, other than stable,
    treated brain metastasis
    • History of another malignancy in the previous 3 years, with a diseasefree
    interval of < 3 years (except for in situ cancer or basal or squamous
    cell skin cancer)
    • Serum calcium > ULN (corrected for low serum albumin
    concentrations)
    • Uncontrolled diabetes (fasting serum glucose level > 200 mg/dL)
    • Pregnancy or lactation
    • Significant history of cardiovascular disease
    • Serious active infection or other serious underlying medical conditions
    • Known HIV positivity
    • Any major surgery, major surgical procedure, open biopsy, open
    pleurodesis, or significant traumatic injury within 28 days prior to Day 1
    of Cycle 1, or an anticipated need for major surgery during the study
    • Known sensitivity to any component of cisplatin or carboplatin
    • (Patients with contraindications to bevacizumab or pemetrexed may
    not be included in those treatment cohorts)
    -Trattamento sistemico precedente per NSCLC non squamoso di Stadio IIIB o IV
    -Evidenza istologica di NSCLC misto con predominanza del tipo a cellule squamose
    -Precedente esposizione a trattamento sperimentale mirato a HGF o Met
    -Pazienti con tumori per i quali è stata confermata la presenza di mutazioni con attivazione di
    EGFR, idonei alla terapia anti--EGFR (per esempio gefitinib o erlotinib), secondo quanto determinato dallo Sperimentatore
    -Patologia nota del sistema nervoso centrale (CNS), diversa dalla metastasi cerebrale trattata e
    stabile (nessuna evidenza di progressione dopo il trattamento e nessuna necessità in atto di
    assumere desametasone, come stabilito tramite esame clinico e imaging cerebrale post-trattamento
    [tomografia computerizzata (CT) o risonanza magnetica (MRI)] alla baseline)
    -Storia di un'altra malignità nei 3 anni precedenti, con intervallo libero da malattia &lt; 3 anni
    -Conta granulocitica &lt;1500/mm3; conta piastrinica &lt;100.000/mm3 ed emoglobina &lt;9,0 g/dl nei 7 giorni precedenti l'arruolamento
    -Tempo di tromboplastina parziale (PTT), rapporto normalizzato internazionale (INR) o tempo di
    protrombina (PT) &gt; 1,5xil limite superiore di normalità (ULN) (tranne per pazienti che ricevono
    una terapia anticoagulante)
    -AST (SGOT), ALT (SGPT), fosfatasi alcalina (ALP) &gt;=2,5xULN; (&gt;= 5xULN con metastasi epatiche]
    -Bilirubina totale &gt;=1,5xULN (tranne per pazienti con diagnosi di malattia di Gilbert).
    -Calcio nel siero &gt;ULN (corretto per basse concentrazioni dell’albumina sierica)
    -Creatinina sierica &gt;1,5xULN o clearance della creatinina calcolata (CrCl) &lt;60 ml/min (Cockcroft e Gault)
    -Diabete incontrollato, come dimostrato da livello di glucosio nel siero a digiuno &gt; 200 mg/dl
    -Gravidanza o allattamento
    -Storia significativa di patologia cardiovascolare
    -Infezione attiva grave
    -Positività HIV
    -Aspettativa di vita &lt; 12 settimane
    -Sensibilità nota a un componente qualsiasi di cisplatino o carboplatino
    -Importante intervento o procedura di tipo chirurgico, biopsia aperta, pleurodesi aperta o lesione
    traumatica significativa nei 28 giorni precedenti il Giorno 1 del Ciclo 1 oppure una necessità
    anticipata di intervento chirurgico importante durante lo studio
    -Assunzione di un farmaco sperimentale nei 28 giorni precedenti l'inizio del trattamento con il farmaco dello studio
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS)
    Sopravvivenza libera da progressione
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS will be evaluated when 48 investigator-assessed PFS events in
    patients with Met diagnostic-positive tumors and 96 PFS events in the
    ITT population have occurred.
    L'analisi di efficacia sarà effettuata quando si saranno manifestati 48 eventi PFS valutati dallo
    Sperimentatore in pazienti con tumori Met-positivi e 96 eventi PFS nella popolazione ITT.
    E.5.2Secondary end point(s)
    • Overall survival (OS)
    • Overall response rate (ORR)
    • Duration of response (DOR)
    • Disease control rate (DCR)
    • Adverse events, including serious AEs
    • Clinical laboratory results and vital signs
    • Pharmacokinetics for all components of study treatments
    -sopravvivenza globale
    -Tasso di risposta globale
    -durata della risposta
    -tasso di controllo della malattia
    -Incidenza, natura e gravità degli eventi avversi, compresi eventi avversi gravi
    -Variazioni nei risultati delle analisi cliniche di laboratorio e nelle misurazioni dei segni vitali
    prima e dopo la somministrazione del farmaco sperimentale
    -misure di esito di farmacocinetica definite come concentrazione ematica di tutti i componenti in studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    Follow-up for survival will continue until all patients have either died, or
    are lost to follow-up, or the Sponsor decides to end the trial, whichever
    occurs first.
    Il followup
    per la sopravvivenza proseguirà fino a quando tutti i pazienti saranno morti, risulteranno persi al
    follow-up oppure fino a quando lo Sponsor non deciderà di terminare lo studio, a seconda dell'evento che si verificherà per primo.
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, QoL, Serum levels and incidence of anti-therapeutic
    Tollerabilità, qualità della vita, livelli sierici e incidenza di ATA contro MetMab
    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 Yes
    E.8.2.3.1Comparator description
    comb.con Paclitaxel+cisplatino o carboplatino
    COMB WITH PACLITAXEL + CISPLATIN OR CARBOPLATIN
    E.8.2.4Number of treatment arms in the trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Colombia
    Israel
    Malaysia
    Mexico
    Philippines
    Taiwan
    United States
    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
    The efficacy analysis will occur when 48 investigator-assessed PFS events in patients with Met diagnostic-positive tumors and 96 PFS events in the ITT population have occurred.
    L'analisi di efficacia sarà effettuata quando si saranno manifestati 48 eventi PFS valutati dallo Sperimentatore in pazienti con tumori Met-positivi e 96 eventi PFS nella popolazione ITT
    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 months26
    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 months26
    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: 169
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 91
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 71
    F.4.2.2In the whole clinical trial 260
    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)
    Currently, Roche does not have any plans to provide MetMAb or other study interventions to patients after the conclusion of the study or any earlier withdrawal. However Roche will evaluate the appropriateness of continuing to provide MetMAb to study patients after evaluating the primary efficacy outcome measure and safety data gathered in the study.
    attualmente Roche non ha un programma per il trattamento o l'assistenza per i soggetti al termine della loro partecipazione allo studio. Roche valuterà se contunuare a fornire MetMab ai pazienti coinvolti nello studio dopo la valutazione dell'esito primario di efficacia e i dati di sicurezza.
    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 Decision2012-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-30
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