Randomization
vomiting, Vomiting
STERILE
Patients were randomized centrally using interactive response technology in a ratio of 1:1:1:1 to 400 mg ferroquine alone, or 400 mg ferroquine plus artefenomel 300, 600, or 1000 mg. The administration of treatments was open label as a single oral dose on Day 0 and was directly observed. Ferroquine was administered in a fasted condition. Artefenomel was prepared as a suspension in sterile water and given approximately 15 min after ferroquine. If vomiting occurred after ferroquine, the patient was not re-dosed, artefenomel was not administered, and the patient received rescue therapy. If the artefenomel dose was vomited within 5 min of administration, the patient was re-dosed. Vomiting within 5–35 min of artefenomel administration did not prompt redosing, but any remaining drug was given. Rescue anti-malarial therapy as per local recommendations was administered to patients before Day 28 if clinically indicated, if the ferroquine dose was vomited, or at Day 29 if not given previously.