Randomisation and masking
By use of permuted block (block size of 6) randomisation, participants were assigned (1:1) to either receive oral tenofovir disoproxil fumarate 300 mg daily, oral lamivudine 300 mg daily, and oral dolutegravir 50 mg daily plus supplemental 50 mg dolutegravir 12 h later or tenofovir disoproxil fumarate, lamivudine, and dolutegravir plus matched placebo 12 h later. Randomisation was stratified by baseline ART status (ART-naive Study pharmacists used sequentially drawn individually sealed opaque envelopes to assign a treatment arm when dispensing medication. Allocation concealment was maintained as only the study pharmacists retained access to the randomisation schedules through a locked storage unit and strict access control. Participants and investigators remained masked for the duration of the study. Masking was achieved using tablets with an identical appearance. The study statistician had access to the randomisation schedules for 6-monthly data and safety monitoring committee meetings.