Statistical analyses
pain
In consideration of the sample size calculation (Supplementary Methods), it was planned to enroll 120 patients per group.For this study, we defined three analysis populations. The full analysis set (FAS) comprised all patients who received at least one dose of study drug and for whom the primary endpoint (i.e., change in pain VAS at rest from baseline to the EOT or discontinuation) could be calculated for modified intention-to-treat analyses. The per-protocol set (PPS) comprised all patients in the FAS, excluding those with major protocol deviations (e.g., eligibility criteria, randomization/blinding violations, or non-compliance with study drug administration). The safety analysis set (SAF) comprised all patients who received at least one dose of the study drug.The primary endpoint was analyzed using the FAS and verified using the PPS by analysis of covariance with treatment group as a fixed factor and the baseline VAS score as a covariate to estimate the adjusted mean change in each group and the between-group difference in adjusted mean change with 95% confidence intervals (CI). Non-inferiority was established if the upper limit of the CI for the between-group difference did not exceed the non-inferiority margin (7.5 mm). Descriptive statistics were also calculated for VAS scores at each visit. Other analyses are described in the Supplementary Methods. SAS version 9.4 (SAS Institute, Cary, NC, USA) was used for all data analyses.