CONSORT 2010 checklist of information to include when reporting a randomised trial*.
(DOC)Click here for additional data file.(PDF)Click here for additional data file.(PDF)Click here for additional data file.The authors would like to thank CRO Axonal-Biostatem (Castries, France) for study management, data management and statistics, and Thierry Radeau Consulting (Epinay-Sous-Senart, France) for medical writing support in accordance with Good Publication Practice (GPP3) guidelines (