Ducloy-Bouthors, Anne-Sophie
Jeanpierre, Emmanuelle
Saidi, Imen
Baptiste, Anne-Sophie
Simon, Elodie
Lannoy, Damien
Duhamel, Alain
Allorge, Delphine
Susen, Sophie
Hennart, Benjamin
Funding for this research was provided by:
French Drug security agency ANSM (003)
French ministry of Health (14-0032)
Article History
Received: 14 April 2017
Accepted: 15 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. According to the ethical approval, informed consent to participate will be obtained from all participants in the study. Informed consent to participate to the pilot study has been obtained from all participants. 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.
: Authors and sponsors have given their consent and defined the publication rules.
: The authors declare that they have no competing interests.
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