Rimbert, Sébastien http://orcid.org/0000-0002-3314-7231
Schmartz, Denis
Bougrain, Laurent
Meistelman, Claude
Baumann, Cédric
Guerci, Philippe
Article History
Received: 11 December 2018
Accepted: 18 July 2019
First Online: 28 August 2019
Ethics approval and consent to participate
: The study will be conducted in accordance with the principles of the Declaration of Helsinki and the Medical Research Involving Human Subjects Act [CitationRef removed]. This study has been approved by a national ethical committee (Comité de Protection des Personnes Ile de France 1) under number CPPIDF1-2018-ND16. The experiment has also been approved by the Agence Nationale de Sécurité du Médicament (<i>N</i><sup>∘</sup> EUDRACT 2017-004198-15). Finally, the study protocol was registered on ClinicalTrials.gov (NCT03362775). All participants provide written informed consent before participating in the trial or extension study.
: Consent for publication will be obtained from each participant prior to participation.
: The authors declare that they have no competing interests.