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Table 1 Number of participants by study population

From: Similar efficacy and safety of artemether-lumefantrine (Coartem®) in African infants and children with uncomplicated falciparum malaria across different body weight ranges

Number of participants Body weight
All 5 to < 15 kg   15 to < 25 kg 25 to < 35 kg
5 to < 10 10 to < 15   
Randomized population 547 168 379 289 63
ITT populationa 535 164 371 288 63
mITT populationb 477 143 334 277 58
Safety population 547 168 379 289 63
  1. Patients could have more than one reason for exclusion from the ITT and mITT populations.
  2. a Reasons for exclusion from ITT population: no relevant post-baseline efficacy assessment (n = 12), no full dose of study medication taken (n = 9) and no P. falciparum at baseline (n = 1)
  3. b Reasons for exclusion from the mITT population were as for the ITT population, and additionally no day 28 parasite count without being a failure prior to day 28 (n = 68), vomiting of replacement dose or two replacements and subsequent vomiting (n = 16), reappearance of parasite but no valid PCR analysis until day 28 (n = 7), switch to rescue for other reasons (n = 4) and use of concomitant anti-malarials other than rescue medication (n = 4)