Author contributions
POINCARE-2 trial was designed jointly by NA and PEB. CHRU Nancy, Inserm, Université de Lorraine, CIC, Epidémiologie Clinique was in charge of data collection, management, analyses, and interpretation in collaboration with the authors. Randomization and data management were supervised by JMV, and statistical analyses conducted by AM, CA, and MS. AM and NA first drafted the manuscript. All authors revised the manuscript critically for important intellectual content. All authors vouch for completeness and accuracy of clinical data and analyses and for adherence to the trial protocol.