Figure 1

Trial profile with mITT and PP populations. RDT = rapid diagnostic test for malaria (Paracheck® ); Pf = Plasmodium falciparum; WH = Weight for Height; mITT = modified Intention to Treat; KM = Kaplan Meier; SAE = Serious Adverse Event; PP = Per Protocol. ^a Second participation excluded from analyses.* Note: one patient was discontinued with recurrent malaria (Pf re-infection, day 30). This patient is listed here among the n = 2 patients pre-maturely discontinued due to SAE (severe malaria). ** Patient was discontinued from participation on day 0 shortly upon enrolment because eligibility criteria were not met: i.e. asexual parasites density was outside the eligibility range (< 2000 or > 200 000 / μl blood). *** Two patients were enrolled with day 0 asexual parasites density outside the eligibility range (< 2000 or > 200 000 / μl blood): n = 1 patient was discontinued on day 0, once the eligibility error was discovered (discontinuation due to incorrect enrolment); n = 1 patient continued the follow-up to day 42. Both patients were excluded from the per-protocol population (protocol deviation). ^# Pre-mature discontinuations other than discontinuations due to adverse event or recurrence of parasitaemia which lead to exclusion from the PP population. ^## For n = 1 patient the care-taker withdrew consent on day 3; for n = 1 patient the care-taker withdrew consent on day 21. ^### n = 1 patient who also missed 2 evening doses is not listed among these n = 19, since the primary reason for exclusion of this patients from PP population was withdrawal of consent by care-taker (day 3) (patient listed among n = 2 consent withdrawn).