Fig. 1

Participant flow through the study from recruitment to study endpoint. ¹been together ≥8 weeks, indicated/confirmed on phone that RSP likely to participate; ²refer to eligibility criteria; ³protocol violation means not in modified intention-to-treat (mITT) primary analysis or per protocol analysis; ⁴eligible for mITT and per protocol analyses if week 4 and/or 12 provided but with missing data, not eligible for safety analysis; ⁵if female participant does not attend clinic visits but does return a swab, eligible for secondary endpoints; ⁶if female attends at week 4 but not week 12, still be eligible for mITT; if no visits but returns a swab, eligible for secondary endpoints; if no visits or swabs, protocol violation. Abbreviations: LTFU, Loss to follow up; W, withdrawn