Study participants.
This study included patients who were randomized to treatment and received at least one dose of their assigned treatment with nifurtimox. Prior to enrollment, written informed consent was obtained from the patient and/or their parents or legally authorized representative(s) according to age and local regulations. Depending on their age, patient assent was also obtained if required by locally applicable laws and regulations in each country. Patients were considered to have completed the study if they completed the 4-year posttreatment follow-up (