5.8. Statistical Analysis
SECONDARY
The efficacy evaluation analysis was primarily conducted on the per protocol set (PPS), with supplementary analysis performed on the full analysis set (FAS). The FAS included subjects who were enrolled in the clinical trial, received the investigational medicinal product at least once, and for whom information on the primary efficacy evaluation results after baseline could be obtained. The FAS was analyzed according to the randomly assigned treatment group. The PPS was defined as the subset of subjects included in the FAS who completed the clinical trial without any major protocol deviations. Statistical analysis was using SASFor the primary outcome analysis, the upper limit of the 97.5% one-sided confidence interval for the difference value (test group–control group) of the MAS score change for wrist flexor muscle tone at 4 weeks after drug administration compared to the baseline is presented. If the difference was smaller than the margin of non-inferiority, it was determined that the test group had demonstrated non-inferiority compared to the control group. In addition, the difference between the two groups was compared using the Wilcoxon rank sum test or the two-sample t-test for the MAS score change of the wrist flexor for each administration group.For the secondary outcome measurements to evaluate the change in DAS and CBS scores from baseline, descriptive statistics for each administration group (number of subjects, median, mean, standard deviation, minimum, maximum) were presented and the difference between the two groups was compared using the two-sample 