Statistical analyses
pain
Efficacy analyses were performed on the per-protocol population which comprised the intent-to-treat patients (ITT) (i.e., all randomized patients with at least one VAS measurement post-baseline) who had no major protocol deviations, completed the VAS measurements within the allowed time frames, and did not take any prohibited concurrent medication (corticosteroids, immunosuppressive, anti-inflammatory, neuromuscular blocking, and pain relief drugs).The primary efficacy analysis was conducted as a test of superiority using covariance model analysis by estimating the two-sided 95% confidence interval (CI) for the difference (test treatment) in the VAS score changes, with the baseline score being used as the covariate and the treatment score as the factor. The difference between the test and the reference treatment was considered significant at 