Chabriat, Hugues
Bassetti, Claudio L.
Marx, Ute
Picarel-Blanchot, Françoise
Sors, Aurore
Gruget, Celine
Saba, Barbara
Wattez, Marine
Audoli, Marie-Laure
Hermann, Dirk M.
Article History
Received: 7 November 2018
Accepted: 13 January 2020
First Online: 3 February 2020
Ethics approval and consent to participate
: The study is performed in accordance with the ethics principles stated in the Declaration of Helsinki 1964, as revised in Fortaleza, 2013.The study protocol, the “Participant information and consent form” document, the “Authorised representative according to local regulations information and consent form” document, the list of investigators document, the insurance documents, the investigator’s brochure of S 44819 are be submitted to (an) Institutional Review Board(s)/Independent Ethics Committee(s) by the investigator(s) or the national coordinator(s) or the sponsor in accordance with local regulations. The study does not start in a centre before written approval by corresponding Institutional Review Board(s)/Independent Ethics Committee(s) has been obtained, the local regulatory requirements have been complied with, and the signed clinical study protocol of each contractual party involved has been obtained.The investigator or a person designated by him/her is to collect written consent from each participant before his/her participation in the study.
: C. Bassetti, H. Chabriat, and D. Hermann declare no competing interests.U. Marx, F. Picarel-Blanchot, A. Sors, C. Gruget-Petazzoni, B. Saba, M. Wattez, and M.L. Audoli are employees at Servier.