Randomisation and follow up
Eligible participants were randomised to the intervention arm or control arm using permuted block randomisation with varying block sizes of 4, 6 and 8 people chosen at random using the SAS software (SAS version 9.4, SAS Institute, Cary, NC, USA.). Each participant had a unique randomisation code. The randomisation list was held in the Electronic Data Capture database (The randomisation code was written and tested by a senior statistician (DW) and the final list was generated by an independent trial statistician (T. Chen, Liverpool School of Tropical Medicine [LSTM], Liverpool, UK), who maintained the randomisation codes. A copy of the participant allocation list was held by the META trial team’s Chief Pharmacist and his assistant, I. Tarimo (both Muhimbili National Hospital, Dar es Salaam, Tanzania). All research and clinical staff remained blinded to the allocation code.Participants were given drug supplies to last them until their next visit plus 6 days’ extra supply in case they were late returning to the clinic. The scheduled visits occurred at 2 weeks and at 1, 3, 6, 9 and 12 months after baseline. Laboratory blood tests of renal and liver function were conducted at 3-monthly intervals. In addition, participants with abnormal baseline laboratory results had unscheduled visits for clinical review and additional tests were immediately conducted to assess potential relatedness with investigational drugs.