Procedures
DISEASE
Arm 1 comprised a once-daily intramuscular injection of 20 mg/kg/day PM (Gland Pharma Ltd.) for 14 days and oral MF (Impavido) BID for 42 days. Arm 2 comprised 5 mg/kg/day intravenous infusion of LAmB on days 1, 3, 5, and 7 (at a total dose of 20 mg/kg) and oral MF BID for 28 days. Children ≤30kg received MF allometric dosing based on sex, weight, and height [Rescue treatment (2.5 mg/kg for 20 days LAmB or, in case of poor tolerance to LAmB, rescue treatment was given at the discretion of the study physician/ investigator) was indicated in case of: failure to respond to treatment at the end of treatment (EOT, Day 42) or 3 months follow-up, progression of disease (lesions worsening over time), reappearance/ reactivation of lesions after an initial healing period, or unable to tolerate the study medication.For arms 1 and 2, in-patient administration of MF was directly observed; adherence was expected to be 100%, unless the patient vomited and could not tolerate re-administration within 30 minutes. PM and LAmB were administered by study staff. Adherence to outpatient treatment of MF was assessed by collecting the drug packaging and checking for any unused drug, and using a simple diary. Outpatient MF treatment was under direct observed treatment (DOT) by the community health worker at the village level, whenever possible, on a daily basis, or followed using telephone contact until completion of MF treatment. Full compliance was assumed if 90–110% of the prescribed doses were administered.Samples of blood and skin for PK measurements of MF, PM, and LAmB were taken according to the schedule of assessments presented in Table A in 