Statistical analysis
The sample size was referenced from a similar previous study [All statistical analyses were performed using SAS® (version 9.4; SAS Institute, Cary, NC, USA). Continuous variables were presented as means ± standard deviation (SD) and categorical variables were presented as frequencies. Data analysis for efficacy was performed using the full analysis set (FAS). Analysis for safety was performed using the safety set. Statistical analysis was performed for data according to protocol criteria. Significant differences in demographic characteristics at baseline were analyzed using the Chi-square test (Fisher’s exact test). Mean comparisons between the two groups were performed using an independent t-test. Statistical analysis between the two groups was performed using an independent t-test for change values before and after 16 weeks of intervention. Within each group, the comparison between before intake and 16 weeks after intake was analyzed using a paired t-test. Differences were considered statistically significant at a p-value < 0.05.