Statistical analysis
EVENTS
The primary hypothesis was that moxidectin and albendazole combination treatment is not inferior to ivermectin and albendazole. Simulations using data based on a study by Barda and colleaguesThe primary non-inferiority analysis was done according to the intention-to-treat principles in the available case population (defined as all participants with any primary endpoint data), with a subsequent per-protocol analysis (defined as all participants with no major protocol deviations, excluding those who did not enter the study because they did not satisfy entry criteria, received no treatment, received the wrong treatment or an incorrect dose, or received concomitant therapy). Eggs per gram of stool were calculated from the geometric mean egg counts multiplied by a factor of 24. For each treatment group, ERRs were calculated using geometric mean egg counts assessed at baseline and 14–21 days after treatment according to the following formula:
To estimate the difference between ERRs and 95% CIs, a bootstrap resampling method with 5000 replicates was used. The geometric SD was calculated as; eAdverse events are presented as frequencies without statistical testing, as recommended by Ioannidis and colleagues.