Table 1.
End point (n for vamorolone 6 vs vamorolone 2 mg/kg/d) | Vamorolone 6 mg/kg/d LSM (SE) vs vamorolone 2 mg/kg/d LSM (SE) | LSM difference (SE) | LSM difference (95% CI) | p Value |
TTSTAND velocity (rises/s) (27 vs 28) | 0.0446 (0.0138) vs −0.0053 (0.0135) | 0.0500 (0.0186) | 0.0126 to 0.0874 | 0.010 |
6MWD (m) (19 vs 21) | 49.6823 (12.5359) vs 14.9190 (12.3367) | 34.7634 (17.0194) | 0.4506 to 69.0761 | 0.047 |
TTCLIMB velocity (tasks/s) (24 vs 23) | 0.1120 (0.0169) vs 0.0589 (0.0172) | 0.0531 (0.0238) | 0.0052 to 0.1010 | 0.031 |
TTRW velocity (m/s) (24 vs 24) | 0.2519 (0.0747) vs 0.1544 (0.0746) | 0.0976 (0.1032) | −0.1099 to 0.3051 | 0.349 |
NSAA (score) (24 vs 23) | 3.0834 (0.8287) vs 2.5933 (0.8259) | 0.4901 (1.1404) | −1.8041 to 2.7843 | 0.670 |
Abbreviations: 6MWD = 6-minute walk distance; LSM = least squares mean; mITT-2 = modified intention to treat–2; NSAA = North Star Ambulatory Assessment; SE = standard error; TTCLIMB = time to climb 4 steps; TTRW = time to run/walk 10 m; TTSTAND = time to stand from supine.