Table 2.

Trial flow chart

	Screening	Enrollment	Every 4 weeks for 1st 24 weeks, then every 12 weeks	Additional evaluations every 24 weeks	Final study visit, time of termination	Premature discontinuation of study treatment	Unscheduled Visits
Informed consent	√
Review of past medical history	√
Review of current complaints		√	√		√	√	√
Medication history	√		√		√	√
Bednet use		√	√		√	√
WHO performance scale		√		√	√	√
Complete blood count, alanine aminotransferase, creatinine	√			√	√	√
Urine pregnancy test	√	√a	√a
CD4 count	√			√	√	√
HIV viral load	√			√	√	√
Filter paper sample		√	√		√	√
Physical examination	√	√ (limited)	√ (limited)	√	√	√	√
Visual acuity assessment		√		√	√	√
Provision of medication		√	√
Pill count and adherence interview			√		√	√

^aUrine pregnancy testing will be performed at all study visits only where pregnancy is suspected