Ethics and regulation
MAY
All the requirements of French Law were fully complied with. An ethics committee (Comité de Protection des Personnes – Tours – Région Centre-Ouest 1) endorsed the protocol on June 28, 2016. The protocol and the database were registered on May 12, 2016 by the French National Data Protection Committee (CNIL) according to the requirements of the declaration of conformity. The protocol was registered on Clinical Trials under the reference NCT02911207.