Khammari, Amir
Nguyen, Jean-Michel
Leccia, Marie-Thérèse
Guillot, Bernard
Saiagh, Soraya
Pandolfino, Marie-Christine
Knol, Anne-Chantal
Quéreux, Gaëlle
Chiffolettau, Anne
Labarrière, Nathalie
Dréno, Brigitte
Funding for this research was provided by:
LABoratoires d’EXcellence IGO (ANR-11-LABX-0016-01)
Article History
Received: 27 August 2019
Accepted: 7 April 2020
First Online: 18 April 2020
Compliance with ethical standards
: The trial complied with all French (AgenceNationale de Sécurité du Médicament et des Produits de Santé, ANSM,” <i>Loi n° 2012–300,</i> 5 Mars<i>2012</i> relative aux recherchesimpliquant la personnehumaine” and all its amendments) and European requirements for the conduct of clinical trials (EuroepanMedicinec Agency, EMA, CPMP/ICH/377/95, EMEA) and the principles of Good Clinical Practices, the 1964 Declaration of Helsinki, received approval for all study sites from the ethics committee of Nantes, France in December 2003 (CPP Ouest IV Nantes n° 553/2005) and is registered at ClinicalTrials.gov under the Identifier: NCT00200577. All patients provided written informed consent prior to inclusion.
: The authors have no conflict of interest to disclose.