2.6. Statistical Analysis
The efficacy evaluation was analyzed with full analysis set (FAS) based on the intention to treat principle and the per-protocol set (PPS), and the safety evaluation was based on the safety set (SS). The FAS comprised participants who had received at least one post-intervention assessment after randomization. The PPS included participants who completed the trial without significant protocol deviations that could have affected the outcomes. The last observation carried forward (LOCF) was adopted for imputing the missing values of results. Analyses were performed by an independent company (Vantage Marketing and Research Consultants Ltd., Guangzhou, China) using statistical software (SPSS