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AS, JCM, DL and MD declare no conflicts of interest. AR reports consultancy fees, speaker fees, research grants (non-personal), and\/or honoraria approved by the institutions from BMS, Novartis, Biogen Idec, Genzyme, Roche, and Merck, all of the above unrelated to this work. The study was supported by a grant from the ARSEP foundation in the name of Fondation de France Foundation. Authors declare that they do not have a financial relationship with the organization that sponsored the research. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results\u201d.","order":1,"name":"Ethics","label":"Conflicts of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All subjects provided written informed consent prior to inclusion in the study.","order":2,"name":"Ethics","label":"Informed consent","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The sponsor (CHU de Bordeaux) and the investigators ensured that the study (ClinicalTrials.gov ID NCT02708927) was conducted in accordance with Act No. 2004\u2013806 of 9 August 2004, Good Clinical Practice (I.C.H. version 4, of 1 May 1996, and decision of 24 November 2006), and the Declaration of Helsinki. This study received approval from the ethics committee (Comit\u00e9 de Protection des Personnes [CPP] Sud-Ouest et Outre-Mer III) (ID-RCB: 2015-A01282-47) and authorization from the French Health Products Safety Agency (Agence Nationale de S\u00e9curit\u00e9 du M\u00e9dicament et des produits de sant\u00e9, ANSM).","order":3,"name":"Ethics","label":"Institutional Review Board Statement","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Grammar and spelling corrections have been made using Wordvice AI\n                      \u00ae","order":4,"name":"Ethics","label":"AI Usage","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"534"}}