Outcomes
infection, recrudescence, infections, fever
RECURRENCE, ADVERSE EVENTS, INFECTIONS, INFECTION, CYP2D6 POLYMORPHISM
The primary outcome was relapse-free efficacy over 6 months, defined as clearance of initial infection without subsequent microscopically confirmed recurrence or receipt of other antimalarial treatment. Secondary outcomes were relapse-free efficacy over 4 months, time to fever clearance, time to parasite clearance, and percentage of patients with recrudescence (genetically homologous recurrence within 14 days) to ensure the blood stage efficacy of dihydroartemisinin–piperaquine. Safety assessments included frequency and severity of adverse events and review of 12-lead electrocardiograms, vital signs, and laboratory values. Tafenoquine pharmacokinetic assessments were also planned.The incidence of genetically homologous infections was established by five microsatellite markers. Additionally, the influence of human CYP2D6 polymorphisms on relapse was explored post-hoc by means of a CYP2D6 activity score system (see 