Ethics approval and consent to participate
All methods were performed in accordance with the relevant guidelines and regulations and all participants provided informed consent. The protocol, information letter and informed consent certificate were approved by the Angers ethics committee and the French Health Products Safety Agency (study number 2014-A00332-45The French Data Protection Agency authorised the collection of identifying data (CCTIRS/CNIL approval number 14.559). The PEPPER trial is registered in the US National Institutes of Health Clinical Trials Registry under number NCT02317003 (15/12/2014). The study was designed and reported in accordance with the CONSORT (Consolidated Standards of Reporting Trial) statement [