VAS for pain at rest and during movement
pain
The adjusted mean change in VAS for pain at rest from baseline to EOT/discontinuation (FAS) was − 22.07 mm for the bilayer tablet group and − 19.08 mm for the IR capsule group, corresponding to a between-group adjusted mean difference of − 2.99 mm (95% CI − 7.96 to 1.99 mm). The upper 95% CI bound was less than the predefined non-inferiority margin of 7.5 mm, demonstrating non-inferiority of the bilayer tablets to the IR capsules (Fig. (A) Non-inferiority analysis of the adjusted mean change in VAS for pain at rest from baseline to EOT (primary endpoint). (B) Change in VAS for pain at rest from baseline to EOT. (C) Change in VAS for pain during movement from baseline to EOT. Values in B and C are mean ± standard deviation. Changes in VAS over time for pain at rest (A) and pain during movement (B). Values are mean ± standard deviation. The proportion of patients with a clinically relevant improvement in pain at rest (at EOT/discontinuation) was numerically greater in the bilayer tablet group (87/124, 70.2%) than in the IR capsule group (69/120, 57.5%). Furthermore, a slightly greater proportion of patients in the bilayer tablet group experienced a clinically relevant improvement in pain during movement (71/124, 57.3% vs 60/120, 50.0%).