Funding for this research was provided by:
French ministry of Health (PHRC 14-0032)
French agency for drug security (ANSN AAP-003)
Received: 14 April 2017
Accepted: 12 December 2017
First Online: 1 March 2018
Ethics approval and consent to participate
: The TRACES trial obtained approval from the competent national authorities (ANSM 201500249926) and the Ethics Committee (CPP 15/50 020216) before beginning the study, in accordance with article L1121-4 of the Public Healthcare Code. This trial has been declared on the clinical trials registration on 13 June 2016 under the number CT 02797119. Registration will be performed in accordance with decree dated 14 November 2006 about gathering data in the national register of individuals participating in biomedical research.
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