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Article History

Received: 23 July 2019

Accepted: 16 October 2020

First Online: 27 October 2020

Ethics approval and consent to participate {24}

: The study was granted ethics approval by the Institutional Review Board of the University Hospital of Nîmes, on November 26, 2016 (ANSM 2015-A01585_44). The research was implemented after a favorable opinion from independent French ethics committees (CPP). The current protocol version (5.0) was approved on 15 October 2018. Any modifications to the protocol will be approved by the CPP before being implemented. An informative letter will be presented to the participants and will state the purpose, the objectives and conduct of the study at any time. Participant consent will be sought and obtained before the entry thereof in the study. A copy of the signed consent will be given to the patient, and a copy will be retained by the investigator; a third copy will be retained by the sponsor. Participation is voluntary, and participants were informed that they could leave the study at any time.

: This is available from the corresponding author on request.

: The authors declare that they have no conflict of interests.