Authors’ contributions
WT conceived and led the study design. ME, FG and SS contributed to the design of the study and protocol. ME and WT are responsible for data management. ME drafted the manuscript. The steering committee includes FG, SS and WT. Endpoint adjudication committee includes WT and FJ. The data monitoring committee is FG and WT, they reviewed the collected data for completeness and accuracy, they are independent from the sponsor. All authors contributed to the manuscript revision and read and approved the final manuscript.