Contribution to authorship
LA, FT and ABM contributed to the design of this study. LA, ALT, CCC, OP included most of the patients. LA, LM, CR and FT conducted the analyses and LA, LM, ABM, ALT, CCC, OP, CR and FT contributed to the interpretation of data. LA, LM and FT drafted the manuscript and all the authors critically revised the manuscript and approved the version to published.
Trial Registration : EPIC trial. ClinicalTrials.gov number, NCT00632567
This study (N° ID-RCB 2006-A00518-43) was approved by the Comité de Protection des Personnes (Ethical Human Subjects Protection Review) Paris-Ile-de-France V of Saint Antoine Hospital PARIS 12 on the 02 October 2007 (n°07709) and French Health Authority on 22 October 2007 (Ref: DGS2007-0188).