Marie, Emilie
Ducarme, Guillaume
Boivin, Marion
Badon, Virginie
Pelerin, Hélène
Le Thuaut, Aurélie
Lamoureux, Zeineb
Riche, Valéry-Pierre
Winer, Norbert
Thubert, Thibault
Dochez, Vincent
Article History
Received: 28 June 2019
Accepted: 23 July 2020
First Online: 3 August 2020
Ethics approval and consent to participate
: The “Patient Protection Committee (CPP) of Paris VIII” approved this protocol on 07/11/2017 as reference RC17_0247. The study will be conducted in compliance with the current approved version of the protocol. This research is classified as noninterventional, without additional blood tests or medication. It was a verbal consent from the patients, without written consent, having been approved by the ethics committee. All participants gave their consent. Any change to the protocol document or informed consent form that affects the scientific intent, study design or patient safety or may affect a participant’s willingness to continue participation in the study will be considered a major amendment. All such amendments will be submitted to the “Comité de protection des Personnes Paris VIII” for approval. Our study has been listed in the ClinicalTrials database since January 15, 2018, as NCT03401255.
: Any authors have financial competing interests. Vincent Dochez is a member of the editorial board (Guillaume Ducarme - Associate Editor) of this journal. The other authors have no non-financial competing interests.
: In accordance with legislative provisions (articles L.1121-3 and R.5121-13 of the French Public Health Code), individuals responsible for the quality control of biomedical studies who have access to confidentiality data shall take all necessary precautions to ensure that this confidentiality is maintained, particularly for data pertaining to the intervention, investigational studies, study participants, and results.