Author contributions
SECONDARY
FB and PS were responsible for the data analysis and interpretation of the present secondary analysis. FB, DNL, and PS drafted the final manuscript and all authors contributed to the critical revision of the manuscript. PS was responsible for obtaining funding. PS, ZS, and BM were involved in obtaining funding, drafting the trial protocol, supervising study sites, drafting the final manuscript of the original EFFORT trial and approving the final version of the current manuscript. The corresponding authors had full access to all the data used and shared the final responsibility for the accuracy of the analyzed data. All authors were involved in data collection and/or interpretation and approved the final version of the manuscript.