Statistical Methods
REGRESSION
We followed a prespecified statistical analysis plan and intention-to-treat principles. Baseline continuous variables were presented as means and SDs. Survey data were summarized by proportions. Outcome comparisons were presented as adjusted means or relative risks, and 95% CIs between treatment groups were calculated using regression models adjusting for the baseline measure of that specific outcome. For dichotomous outcomes, log-binomial regression was used, and for continuous outcomes, linear regression was used. Analyses were conducted using R (version 3.5.2; R Foundation for Statistical Computing) packages. Statistical tests were 2-tailed, with a 5% significance threshold.Although endeavoring to capture outcome data within 1 month of the 6-month time point, we prespecified that results obtained 4 to 13 months after randomization were acceptable but as protocol deviations. As this was a pragmatic trial, the exact timing of the outcome assessment could not be controlled as it was based on routine care. A sensitivity analysis that restricted the data to results from 5 to 8 months after randomization found no impact on the final conclusions.Differences in the effect of the intervention on the primary outcome (SBP) for subgroups were explored using prespecified risk factors. A similar prespecified analysis was undertaken for HbA