2.6. Statistical analysis
SEPARATION
The original sample size was determined to be 60 in total, which would provide 85% power, with a two-sided significance level of α = 0.05. Considering the factors of separation, the sample size was increased by 20%, and the final sample was 72, which was tested in three centers, and there were at least 16 but no more than 36 in each center.Unless otherwise stated, analyses were performed based on the full analysis set (FAS), which is defined as the set of all randomized patients who have used the experimental method at least once. The effectiveness analysis of this study will be conducted based on the full analysis set and the per-protocol set (PPS), all baseline demographic statistics will be analyzed based on the full analysis set, and the safety evaluation will be conducted on the safety set (SS).For effectiveness analysis, the primary endpoint (success rate of task) was evaluated using the Bland–Altman plot (All statistical analyses were performed using SAS 9.4 statistical professional analysis software. A 