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    Summary
    EudraCT Number:2012-005542-38
    Sponsor's Protocol Code Number:MK-8931-019
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-24
    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 ConcernedFinland - Fimea
    A.2EudraCT number2012-005542-38
    A.3Full title of the trial
    A Phase III, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Clinical Trial to Study the Efficacy and Safety of MK-8931 (SCH 900931) in Subjects with Amnestic Mild Cognitive Impairment Due to Alzheimer’s Disease (Prodromal AD).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety and Efficacy Study for Alzheimer's Disease (Prodromal AD)
    A.3.2Name or abbreviated title of the trial where available
    An Efficacy and Safety Trial of MK-8931 (SCH 900931) in Subjects with Prodromal AD (APECS)
    A.4.1Sponsor's protocol code numberMK-8931-019
    A.5.4Other Identifiers
    Name:SCH 900931Number:SCH 900931
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive, P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number001267305-7678
    B.5.5Fax number001267305-6440
    B.5.6E-mailmichael.egan@merck.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 nameMK-8931
    D.3.2Product code MK-8931
    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 INNMK-8931
    D.3.9.2Current sponsor codeMK-8931, SCH900931
    D.3.9.3Other descriptive nameSCH 900931
    D.3.9.4EV Substance CodeSUB31364
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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.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 nameMK-8931
    D.3.2Product code MK-8931
    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 INNMK-8931
    D.3.9.2Current sponsor codeMK-8931, SCH900931
    D.3.9.3Other descriptive nameSCH 900931
    D.3.9.4EV Substance CodeSUB31364
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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
    prodromal Alzheimer's Disease
    E.1.1.1Medical condition in easily understood language
    early Alzheimer’s Disease
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the efficacy of two doses of MK-8931 based on overall clinical progression in subjects with prodromal Alzheimer's Disease (AD).
    • To assess the safety and tolerability of two doses of MK-8931 in the treatment of subjects with prodromal AD.
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of two doses of MK-8931 in slowing clinical decline and disease progression in subjects with prodromal AD.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood) and CSF specimens collected during this clinical trial. This research may include genetic analyses (DNA), gene expression profiling (RNA), proteomics, metabolomics (serum, plasma) and/or the measurement of other analytes. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately
    consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.

    CSF substudy- A Companion Diagnostic Clinical Study of Luminex xMAP Tau/Amyloid Assay in Subjects with Amnestic Mild Cognitive Impairment due to Alzheimer's Disease (Prodromal AD) who are enrolled into Merck MK-8931 Pivotal Phase III Clinical Trial (Study No. MK-8931-019). The xMAP Tau/Amyloid Assay is a quantitative mmunoassay used on the FLEXMAP 3D instrument for the detection of total Tau protein and amyloid beta (1-42) peptide from cerebrospinal fluid samples of patients
    with amnestic mild cognitive impairment (aMCI). The xMAP Tau/Amyloid Assay is intended to aid in the identification of prodromal AD patients for whom it is appropriate to treat with MK-8931 based on a the ratio of total Tau protein concentration to amyloid beta 1-42 peptide concentration in the CSF. The CSF substudy has two distinct objectives: 1) to evaluate change from baseline in AD biomarkers at Week 104 and 2) to support development of a CSF companion or standalone diagnostic.

    Amyloid PET Substudy: Only subjects randomized in this trial with both a new [18F]-flutemetamol PET scan and new MRI at screening will be allowed to participate in the PET substudy. For patients participating in the PET substudy to evaluate change from baseline in brain [18F]-flutemetamol tracer standard uptake value ratio at 104 weeks of treatment (N = 100 patients/treatment arm), an End of Treatment PET scan should be performed within 4 weeks before the clinical visit (Visit 12) and before trial medication is discontinued. All Visit 12 PET scans will be acquired using [18F]-flutemetamol.
    E.3Principal inclusion criteria
    In order to be eligible for participation in this trial, the subject must:
    1. Be ≥ 50 and ≤ 85 years of age at the Screening Visit.

    Meet the following criteria (2-5) for a diagnosis of prodromal AD:
    2. Each subject must report a history of subjective memory decline with gradual onset and slow progression for at least one year before Screening, that is either corroborated by an informant who knows the subject well or is documented in medical records.
    3. Each subject must have objective impairment in episodic memory at Screening that is ≥ 1.0 SD below the appropriate population mean as measured by the RBANS
    (Repeatable Battery for the Assessment of Neuropsychological Status). To meet this criterion, an RBANS delayed memory index score of ≤85 is required for entry. (Note: the proportion of subjects with RBANS delayed memory index scores ranging from 79 to 85 (approximately 1.5 to 1.0 SD below the appropriate population mean), inclusive, will not exceed 10-30% of the total number randomized).
    4. Each subject must have general cognitive function and activities of daily living sufficiently intact, based on clinical assessment, so as not to meet criteria for mild AD dementia (based on DSM-IV-TR and NINCDS- ADRDA criteria).
    5. Each subject must have a positive amyloid imaging PET scan using [18F]flutemetamol at Screening* or positive CSF tau:Aβ42 ratio at Screening (see Trial Manuals for details). PET is the primary inclusion tool for the trial. Subjects who fail to meet inclusion criteria based on PET but qualify based on CSF will be enrolled in a separate CSF subgroup of the trial. (Refer to Protocol Section 7.1.3.4 for direction regarding initiation of CSF collection in the trial.) *Subjects with a prior positive amyloid imaging PET scan or a Screening PET scan with florbetaben or florbetapir may be enrolled without a Screening flutemetamol scan with Sponsor approval (see Section 7.1.2.5.7).
    6. Have an MMSE score ≥ 24 at Screening.
    7. Be able to read at a 6th grade level or equivalent, as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude mental retardation.
    8. If receiving an acetylcholinesterase inhibitor, memantine, medical food/supplement (e.g., vitamin E), and/or herbal medications for AD, be on a stable dose for at least the three months before Screening, and the subject must be willing to remain on the same dose for the duration of the trial. The treatment and dose that the subject is receiving at Screening must not be changed during the trial unless medically necessary to ensure subject safety. Additional treatments [including
    herbal medications] for AD that are not specified in the protocol must not be initiated during the trial. The subject and trial partner must agree that they do not plan
    to discontinue treatment or initiate additional AD treatments during the trial unless medically necessary. (See Section 5.5.2 for additional details regarding use of other AD therapy.)
    9. Have a reliable and competent trial partner/informant who must have a close relationship with the subject, have face to face contact at least three days a week for a minimum of six waking hours a week (or more in accordance with local requirements), be willing to accompany the subject to all required trial visits, and be willing to monitor compliance of the administration of the trial medication. The trial partner/informant should understand the nature of the trial and adhere to trial requirements (e.g., dose, visit schedules, receive phone calls, and evaluations).
    10. Have results of clinical laboratory tests (complete blood count [CBC], blood chemistries, thyroid stimulating hormone [TSH], and urinalysis) within normal limits or clinically acceptable to the investigator at Screening.
    11. Have results of a physical examination, vital signs, and ECG within normal limits or clinically acceptable to the investigator at Screening. (read rest in the protocol)
    E.4Principal exclusion criteria
    1. Has a Rosen-modified Hachinski Ischemia Score > 4 at Screening (i.e., evidence of vascular dementia).
    2. Has a known history of stroke or evidence from screening imaging scan (e.g., MRI or CT) that is clinically important in the investigator's opinion.
    3. Meets the criteria for a diagnosis of AD dementia, including probable or possible AD, based on DSM-IV-TR or NINCDS-ADRDA [21] criteria at Screening or Baseline.
    4. Has evidence of a clinically relevant neurological disorder other than the disease being studied (i.e., prodromal AD) at Screening, including but not limited to: vascular dementia, parkinsonism, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, progressive supranuclear palsy, neurosyphilis, dementia with Lewy bodies, other types of dementia, mental retardation, hypoxic cerebral damage, cognitive impairment due to other disorders, or head trauma with loss of consciousness that led to persistent cognitive deficits.
    5. Has a history of seizures or epilepsy within the last five years before Screening.
    6. Has evidence of a clinically relevant or unstable psychiatric disorder, based on DSM-IV-TR criteria, including schizophrenia or other psychotic disorder, bipolar disorder, major depression, or delirium. Major depression in remiss ion is not exclusionary.
    7. Has evidence of a current episode of major depression based on investigator's judgment. A score on the 15-item Geriatric Depression Scale (GDS) of 5 or more requires an assessment by an appropriate health care professional to evaluate for the presence of major depression. Subjects with a score of 5 or more who are not diagnosed with major depression following such an assessment may be included in the trial.
    8. Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicide Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Subjects must be excluded if they report suicidal ideation with intent, with or without a plan or method (e.g., positive response to items 4 or 5 in assessment of suicidal ideation on the C-SSRS) in the past two months or suicidal behavior in the past six months.
    9. Has a history of alcoholism or drug dependency/abuse within the last five years before Screening.
    10. Does not have an MRI scan obtained within 12 months before Screening available for central review and is unwilling or not eligible to undergo an MRI scan (e.g., metal implants, obesity) at the Screening Visit (see MRI Procedure Manual and Imaging Charter for details). Exception: A head CT scan obtained at Screening or within 12 months before Screening may be accepted for evaluation of the eligibility criteria on a case-by-case basis, as approved by the Sponsor (e.g., when MRI is contraindicated for the subject). The head CT must be suitable for central review. Note: Once 20% of subjects have been randomized based on historical MRI or CT scans, no further historical MRIs or CT scans will be accepted.
    11. Has an MRI scan obtained at Screening that shows evidence of a neurological disorder other than prodromal AD or:
    - evidence of a prior macrohemorrhage,
    - symptomatic vasogenic edema in the investigator´s judgment,
    - > 3 lacunar infarcts over 10 mm each, or
    - any other clinically significant finding that may account for their cognitive impairment, including but not limited to: brain tumor, large or strategically located cortical or subcortical infarct, or severe white matter disease equaling a rating of 3 on the age-related white matter changes (ARWMC) scale.
    An MRI that was done within 12 months before the Screening visit that is available for review by the central MRI reading vendor is also acceptable for evaluation of the eligibility criteria. A head CT scan obtained at Screening or within 12 months before Screening may be accepted instead of MRI on a case-bycase basis, as approved by the Sponsor (e.g., when MRI is contraindicated for the subject). (read rest in the protocol)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change from Baseline in the Clinical Dementia Rating Sum of Boxes (CDR SB) score at Week 104.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Week 104
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints are:
    • the time to progression to probable AD dementia
    • the mean difference between the last (Week 104) and first (Week 13) postdose timepoint in CDR-SB
    • the change from Baseline at Week 104 in the 3-domain composite cognition score (CCS-3D)
    • the change from Baseline at Week 104 in total hippocampal volume
    • the change from Baseline at Week 104 in CSF total tau
    • the change from Baseline at Week 104 in composite cortical amyloid SUVR assessed with amyloid tracer [18F]Flutemetamol using PET imaging
    • the change from Baseline at Week 104 in the Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory (mild cognitive impairment [MCI] version) (ADCS ADLMCI) score

    E.5.2.1Timepoint(s) of evaluation of this end point
    • progression to probable AD dementia: Weeks 2, 6, 13, 26, 39, 52, 65, 78, 91, 104
    • Mean difference in CDR-SB: Weeks 13 and 104
    • CCS-3D: Baseline, Week 104
    • Total hippocampal volume: Screening, Week 104
    • CSF total tau: Screening, Week 104
    • Cortical amyloid SUVR: Screening, Week 104
    • ADCS-ADLMCI: Screening, Week 104
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Finland
    France
    Germany
    Hungary
    Ireland
    Italy
    Japan
    Korea, Republic of
    Netherlands
    New Zealand
    Norway
    Poland
    Spain
    Switzerland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1323
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with mild cognitive impairment who may progress to dementia during the trial
    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 442
    F.4.2.2In the whole clinical trial 1350
    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)
    Subjects who have completed the trial, demonstrated acceptable compliance with trial medication, and have not initiated acetylcholinesterase inhibitors or memantine during the trial will be eligible for enrollment in the separate extension protocol (if approved locally). In the extension study, all subjects, including those who initially received placebo in the current protocol, will receive active drug.
    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 Decision2013-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    Patient Information Sheet and consent form and procedure
    Recruitment procedure
    N.Date of Ethics Committee Opinion2014-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-17
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