Follow-up assessments.
CHAGAS DISEASE
At annual follow-up visits, patients underwent a physical examination, including measurements of height, weight, and vital signs. Body mass index, treatment-related AEs, and AEs caused by procedures required by the protocol were also recorded. In addition, a standard 12-lead ECG was performed at the discretion of the investigator, and details of any concomitant medications were recorded. Intermediate follow-up visits were conducted by telephone approximately 6 months after the 2- and 3-year follow-up visits to identify any potential clinical symptoms of Chagas disease. During these two intermediate visits, qualified staff interviewed patients and/or their legally authorized parents or representatives. In case of suspected findings, an unscheduled visit to the research site was requested to initiate appropriate diagnostic evaluations.