Statistical analysis
non-improvement
SECONDARY
The primary endpoint was evaluated on a 7-point Likert scale, with 1 to 3 points defined as improvement and 4 to 7 points as non-improvement. The secondary endpoint was evaluated on a 5-point Likert scale, with 1 to 2 points defined as improvement and 3 to 5 points as non-improvement. The difference in population proportions for improved/non-improved binary data will be analyzed using a McNemar test. Participants with missing data will be excluded from the analysis, and no interim analyses will be performed.