Funding for this research was provided by:
Direction Générale de l’offre de Soins (PREPS-2015-0098, INca-DGOS-Inserm6038)
Fondation de France
Received: 4 October 2018
Accepted: 11 December 2018
First Online: 15 January 2019
: Not applicable.
: The study is conducted in accordance with the Helsinski declaration and the French laws and regulations (Code de la Santé Publique, article L.1121-1 / Loi de Santé Publique n°2004-806 du 9 août 2004 relative à la politique de santé publique et ses décrets d’application du 27 août 2006) and the International Conference on Harmonization (ICH) E6 Guideline for Good Clinical Practice. Regulatory monitoring will be performed by the sponsor. The sponsor needed the approval of the French authorities, including the French ethics committee (Comité de Protection des Personnes Sud Méditerranée I (CPPSM1)), version 2 of the PREDOMOS protocol submitted on march 23rd 2016 reference number 16 26 was approved on the 26th may 2016 for all 10 participating centers, the French drug and device regulation agency (Agence Nationale de Sécurité du Médicament (ANSM), registry number 2015-A01976-43) approved on the 29th June 2016, before beginning the study. Substantial changes to the protocol (revised version 4) was approved on May 29th 2018 by the ANSM and on June 25th 2018 by the CPPSM1. The ClinicalTrials.gov identifier is NCT02829762. Informed consent was obtained from all subjects.
: Informed consent was obtained from all subjects.
: The authors declare that they have no competing interests.
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