Tréhout, Maxime
Leroux, Elise
Bigot, Lucile
Jego, Solenne
Leconte, Pascal
Reboursière, Emmanuel
Morello, Rémy
Chapon, Pierre-Alexandre
Herbinet, Aline
Quarck, Gaëlle
Dollfus, Sonia http://orcid.org/0000-0002-6051-1748
Funding for this research was provided by:
European union and Normandy County Council
Article History
Received: 11 December 2019
Accepted: 4 May 2020
First Online: 26 May 2020
Compliance with ethical standards
:
: MT participated in educational conferences for the following industrial laboratories: Otsuka, Lundbeck, and Janssen. SD has been an expert and consultant or participated in educational conferences for the following industrial laboratories or companies: Gedeon Richter, Lundbeck Otsuka, Roche, Takeda, Fabre, Janssen, ONO Pharma and Verasci. She also has a license agreement on SNS with MedAvante-ProPhase. EL, SJ, PL, ER, RM and GQ have no competing conflicts. AH is the manager of the V@Si company, and LB is employed by V@Si. PA is employed by Bodycap Company.
: The protocol was submitted to the French Health Authority, namely, the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), for formal approval to conduct the study conduct and to ensure that the study meets the local regulations of a properly constituted Ethics Committee. The project was approved by Health Authorities (ANSM) on 19 July 2016 (ID-RCB number 2016-A00930-51) and by the local ethical committee (Comité de Protection des Personnes, CPP Nord-Ouest IV, France) on 10 January 2017 in compliance with French regulations. The trial was registered at ClinicalTrial.gov on 25 August 2017 (NCT03261817). Initial information about the study is given to eligible participants by the regular staff during a routine appointment or by coworkers. Further detailed written and oral information about the trial are then provided by the project coworker. Voluntary participation is assured, and participants can withdraw at any time and receive standard treatment regardless of whether they choose to participate. Each participant provides written informed consent before any intervention is started.
: The current PEPSYV@SI protocol version is 5 dated 6 March 2018. The first participant was recruited in September 2017, and the study is currently enrolling participants. The study is expected to be completed in December 2021.