Statistical analysis
death, ±2, insomnia
ADVERSE EVENTS, SECONDARY
We assumed that 85% of participants would achieve virological suppression at week 24.The primary outcome analysis was by modified intention to treat, which included all participants who received at least one dose of dolutegravir, and excluded those who switched from dolutegravir because of wishing to become pregnant, becoming pregnant, transfer out of the study for non-clinical reasons, and death from non-HIV-related and non-drug-related causes (as assessed by the study investigator). The per-protocol analysis included the same exclusions as modified intention to treat, but also excluded any participants lost to follow-up, missing an HIV-1 RNA measurement in the study visit window (±16 days around a visit date), and participants switched from dolutegravir for reasons other than failure of the regimen. The proportions of participants with virological suppression were determined with 95% CI. Between-group differences for secondary endpoints, where relevant, were analysed by use of χDried blood spot tenofovir diphosphate concentrations were used to measure adherence based on predefined concentration criteria for men and women.The time windows for dolutegravir trough concentrations were 12 h (±2 h) for participants on supplemental dosing with placebo or dolutegravir (defined as 12-h post-dose concentrations for the supplemental arm and 24-h post-dose concentrations for the placebo arm), and 24 h (±4 h; defined as 24-h post-dose concentrations in both arms). Participants still on supplemental dolutegravir or placebo at weeks 24 and 48 were excluded from analyses at these timepoints. Dolutegravir trough concentrations are expressed as geometric means with 90% CIs, and represented as proportion of participants above the PA-ICFor the safety analysis, we report the proportions of participants with grade 3 or 4 adverse events in either arm and all serious adverse events. ISI results were expressed as proportion of participants with any treatment-emergent insomnia (at least subthreshold insomnia, ISI questionnaire score ≥8) after baseline and MMS results as the proportion of participants with a change in score of at least one point from baseline.Statistical analyses were done with Stata (version 16.1). The study is registered with 