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Article History

Received: 11 October 2018

Accepted: 24 January 2019

First Online: 6 February 2019

Ethics approval and consent to participate

: Consent for participating to the study is signed by each participant after they received a full explanation in person, with the opportunity to ask questions. All participants have the right to decline participation or withdraw from the study at any time without giving a reason. Patients who were not able to provide their written consent were not included in the study. The study protocol, information brochure and informed consent procedure were approved by the medical ethics committee for Human (Comité de protection des personnes d’Ile de France 1, 6th November 2017) and the study was registered in clinical trial (NCT03435705).

: Not applicable.

: C.P, R.S, J.W, N.H, A.P-M and C.H report no competing interests. J-F.D has received research support from Roche, outside the submitted work.The sponsor is the Direction de la Recherche Clinique et de l’Innovation at the Bordeaux University Hospital. The sponsor has no role in collection, management, analysis, interpretation of data, writing and decision to submit this paper.

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