Authors’ contributions
PP: conceptualization, writing, and revision. AJ: conceptualization, AG: conceptualization, DP: conceptualization, SK: conceptualization, PSM: conceptualization, EV: conceptualization, MBS: conceptualization, DSC: conceptualization, LK: conceptualization, AB: conceptualization, trial design, statistical plan, writing, and revision. The authors read and approved the final manuscript.