The patients were randomized into control and intervention arms in this open, single-blinded trial. The patients in the control arm received artemether-lumefantrine tablets (20/120 mg) (Coartem®, Novartis Pharma, Switzerland) in accordance with their body weight and the Tanzanian national treatment guidelines for uncomplicated P. falciparum malaria, i.e. twice a day for 3 consecutive days, as follows: one tablet to patients weighing 5–14 kg; two tablets to children weighing 15–24 kg; three tablets to children weighing 25–34 kg and four tablets for patients with a weight above 35 kg. In the intervention arm, patients received artemether-lumefantrine according to the protocol described above for 6 consecutive days. In addition to this, a single dose of 0.25 mg/kg primaquine (Primaquine phosphate, Sanofi) was given together with the last dose of artemether-lumefantrine as supported by modelling data, which suggest that a later primaquine dose has improved gametocidal effect compared to giving with first dose [24 (link)]. ECGs were performed by a qualified physician for both treatment arms, at two time points, i.e. before enrolment and 4–5 h after the 12th (final) dose of artemether-lumefantrine in the extended treatment arm and at the 12th visit (3 days after the last dose) for the control arm.
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