Figure 2.

Trial profile. A: Patient moved to London—no forwarding address so unable to transfer patient; does not wish to continue the study due to organizational reasons; advice from study team following MRI incidental finding; to enter another clinical trial; eGFR less than 60 at screening; on nevirapine. B1: Concerned about leg swelling (not seen as an AE, saw GP, decided to stop drug). B2: Medication ran out 2 days before final visit; appointment missed—participant thought he should stop treatment before reschedule as canceled date 48 week; patient lost pills and failed to tell the research team until week 48 visit. C1: Patient has left the country; patient preference. C2: patients ran out of medication. D1: Patient developed a cough, wanted to discontinue study medication; Taking rampiril (GP’s orders); switch in ARV drug; not able to commit to study; eGFR low at baseline, did not meet eligibility criteria; did not return for appointment, did not respond to contacts; decided to become pregnant. D2: Patient ran out of medications and was due for his week 48 visit only a few days later; low eGFR; patient ran out of medication—new stock not collected; forgot to take them when on holiday abroad; ran out of medication; did not have enough telmisartan—could not come to pick up extra medication; patient usually takes telmisartan at nighttime—so did not take today before visit. ^aOne patient was randomized in arm B. The usual nurse is on extended leave and before leaving had asked for a number of patients to be randomized in her absence. Unfortunately, the cover nurse incorrectly assumed that she just randomize the patient immediately. The patient was not present at the time of randomization. ^bScreening data are missing for 3 patients. Abbreviations: AE, adverse event; ARV, antiretroviral; eGFR, estimated glomerular filtration rate; GP, general practioner; MRI, magnetic resonance imaging.