Statistical Analyses
Data were exported from the 2wT web-based database and verified using the NDoH paper-record system. Descriptive statistics were calculated to describe the baseline characteristics and number of in-person clinic visits in each study arm. They included median and inter-quartile range (IQR) for the number of clinic visits and frequency for the number of in-person clinic visits. Cumulative AEs and the mean difference in proportions were compared by study arm using the Wilson score method and Manning score method, respectively, and 95% CI for proportions were calculated for both methods. The population for the primary safety outcome analysis (cumulative AEs) included all participants who made at least 1 visit between days 1 and 22. Secondary outcome analysis (AEs identified on day 14) included all participants who made a visit between days 13 and 22. The mean number of in-person clinic visits, excluding study visits, was compared between the 2 arms using a 2-tailed 