Statistical Analysis
The sample size calculation was powered to detect the primary outcome of HbAWe followed international guidelines for analysis and reporting of clinical trial intention-to-treat principles. To test group differences in HbAThe primary analysis included all available data for each outcome. Likelihood-based mixed-effects models produce valid inferences in the presence of data missingness provided that the missing data mechanism is ignorable, and these models are appropriate for analyzing incomplete repeated-measures data in randomized clinical trials. Given the presence of missing data, we conducted 2 sensitivity analyses. First, we repeated the primary analysis using a completer data set composed of participants with HbA