Statistical analyses.
cardiomyopathy
CARDIOMYOPATHY
In the primary outcome analysis, the difference in the incidence rate of patients treated with nifurtimox with seronegative conversion (60-day regimen) and the estimated seronegative rate from a historical placebo control group was tested using a Poisson two-sided 95% exact CI. The historical control group comprised children 6 to 12 years of age and seropositive for Recombinant ELISA OD values and total purified antigen ELISA were analyzed descriptively. The changes from baseline were summarized to show any serial reductions in OD values. Baseline was defined as the OD values of the same ELISAs measured at visit 1. The number of patients who showed seronegative conversion and no evidence of established cardiomyopathy was calculated overall and by treatment regimen. Baseline, efficacy, and safety analyses were performed using the full analysis set, based on patient randomization and treatment.