2.8. Statistical analysis
SECONDARY
The intention-to-treat analysis will be applied, and the data of every randomized subject will be analyzed each month, regardless of lost to follow-up or withdrawal from the study. Follow-up loss or withdrawal from the study will be considered treatment failure. Because we expect possible treatment failure during the 3-month follow-up period, linear mixed model will be used to analyze the secondary continuous variables. Adjustments will be made for the baseline values to 0 to compare the decrements of the secondary outcomes at 3 months. The categorical variables will be presented as absolute numbers and percentage. The continuous variables will be presented as the mean with standard deviation, 95% confidence interval, or median and interquartile range. To compare the demographic data of the 2 groups, the chi-square or Fischer exact tests will be used to assess categorical variables and the unpaired 