Author contributions
G.R., M.V.D.B., F.S. and D.G. conceived the study. All authors, except for F.S., M.V.D.B. and G.R., participated in OLTRE study procedures, along with study nurses, clinical research coordinators and other study-center staff. FS performed the statistical analyses, G.R. and M.V.D.B. performed the mathematical modeling. G.R., M.V.D.B., F.S. and D.G. interpreted study results and wrote the first manuscript draft. All authors revised and approved the final submitted manuscript.