Contribution to autorship
All authors contributed substantially to the work, provided important intellectual content, had full access to data and had the final responsibility for the decision to submit for publication. ASB (coordinating investigator) had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. All members of the scientific committee (ASB, FJM, AM, CH and JMG) participated actively in the trial design, the monitoring of inclusions, data validation, data analysis and interpretation; they also demonstrated strong commitment to informing and motivating the study investigators throughout the trial. All investigators (FB,JC,AL,TR,FB,FV,AL and FIDEL Working group investigators) contributed actively to the inclusions, their monitoring, data validation and analysis.