Study withdrawal
malaria, CRF
MALARIA, ADVERSE EVENTS, DISEASE, CRF, ADVERSE EVENT
Patients, parents, or guardians were free to withdraw from the study or to stop taking treatment at any moment, irrespective of the reason. Patients were withdrawn following the investigator’s decision in case of onset of any danger signs of severe malaria or any adverse event justifying treatment discontinuation. Early study withdrawal was documented by the investigator on the case report form (CRF). When possible, patients were evaluated according to the end-of-study visit procedures. Patients presenting severe disease or adverse events were referred for medical care.The study team made a phone call to remind the patient prior to each visit. At each visit, patients were given an allowance for travel expenses. In cases where a patient missed a visit, the study team visited the patient’s home up to three times. If the patient was not available for the follow-up after three attempts, they were declared “lost to follow-up”. For patients lost to follow-up, the CRF was completed up to the last visit attended.No patients prematurely withdrawn from the study were replaced.