Table 2.
Variable | Alv (Mean ± SD) | Control (Mean ± SD) | Alv-Control (Mean ± SD) | p-value |
---|---|---|---|---|
CSS | 0.18 ± 0.05 | 0.20 ± 0.07 | −0.02 ± 0.07 | <0.0001 |
Pain (NRS) | 0.09 ± 0.09 | 0.09 ± 0.09 | 0.00 ± 0.04 | <0.0001 |
The Wilcoxon signed rank test for non-inferiority of Alv compared to control was significant (p < 0.0001), indicating that mean CSS and NRS values in Alv treated arms were not worse by more than one score point compared to control treated arms. Mean ± SD, PP collective, n = 18.