Randomization, Allocation Concealment, and Masking
Participants were randomly assigned (1:1) to a second-line regimen consisting of tenofovir (300 mg), lamivudine (300 mg), and dolutegravir (50 mg), given as a once-daily fixed-dose combination tablet, with an additional lead-in dose of dolutegravir (50 mg) or placebo taken 12 hours later for the first 14 days. An independent pharmacist generated the randomization sequence before trial commencement using block randomization (block size of 10). The study pharmacists used sequentially drawn individually sealed opaque envelopes to assign a treatment arm when dispensing medication. All participants and study staff involved in clinical care were blinded to treatment allocation.