4.7. Study Approval
RECRUITMENT, RECRUITMENT
The trial protocol was approved by the ethics committee “CPP Sud-Méditerranée IV” under reference number 2013-A00115-40. Recruitment was performed between October 2015 and March 2017. Follow-up continued until September 2018. All analyses in the published protocol and analysis plan were specified before the completion of patient recruitment and biologic testing. Written informed consent was obtained from patients. The trial was monitored by the Montpellier University Hospital acting as the sponsor.