TABLE 4.
One-way repeated measure ANOVA analysis within the group with time.
| Parameter | Day 0 | Day 5 | Day 30 | Day 60 | Day 90 | p-value a |
|---|---|---|---|---|---|---|
| Physicians Global Assessment | ||||||
| Placebo | 4.94 ± 0.67 | 4.63 ± 0.76 | 4.78 ± 0.75 | 4.63 ± 0.91 | 5.06 ± 0.98 | 0.07 |
| p-value b | 0.14 | 0.79 | 0.32 | 0.91 | ||
| BSE-150 | 4.88 ± 0.49 | 4.59 ± 0.56 | 5.19 ± 0.74 | 5.97 ± 1.06 | 6.78 ± 0.71 | <0.001 |
| p-value b | 0.08 | 0.03 | <0.001 | <0.001 | ||
| BSE-300 | 4.84 ± 0.51 | 4.74 ± 0.86 | 5.31 ± 0.82 | 6.16 ± 1.24 | 7.41 ± 1.07 | <0.001 |
| p-value b | 0.51 | 0.005 | <0.001 | <0.001 | ||
| EQ5D index | ||||||
| Placebo | 0.51 ± 0.06 | 0.53 ± 0.06 | 0.58 ± 0.07 | 0.58 ± 0.08 | 0.61 ± 0.16 | 0.005 |
| p-value b | 0.44 | 0.001 | 0.003 | 0.003 | ||
| BSE-150 | 0.52 ± 0.04 | 0.54 ± 0.08 | 0.64 ± 0.09 | 0.71 ± 0.06 | 0.75 ± 0.10 | <0.001 |
| p-value b | 0.51 | <0.001 | <0.001 | <0.001 | ||
| BSE-300 | 0.55 ± 0.04 | 0.55 ± 0.11 | 0.64 ± 0.11 | 0.73 ± 0.07 | 0.79 ± 0.09 | <0.001 |
| p-value b | 0.94 | <0.001 | <0.001 | <0.001 | ||
| EQ5D Health score | ||||||
| Placebo | 41.06 ± 1.08 | 43 ± 1.32 | 46.38 ± 1.32 | 48.88 ± 1.46 | 52.81 ± 1.97 | <0.001 |
| p-value b | 0.21 | <0.001 | <0.001 | <0.001 | ||
| BSE-150 | 38.78 ± 1.25 | 43 ± 1.22 | 47.34 ± 1.65 | 56.75 ± 1.77 | 60.88 ± 2.30 | <0.001 |
| p-value b | 0.005 | <0.001 | <0.001 | <0.001 | ||
| BSE-300 | 39.35 ± 1.03 | 43.24 ± 1.1 | 46.91 ± 1.69 | 57.65 ± 1.32 | 64.03 ± 2.21 | <0.001 |
| p-value b | 0.002 | <0.001 | <0.001 | <0.001 | ||
| Number of laps | ||||||
| Placebo | 4.969 ± 0.23 | 5.094 ± 0.22 | 5.031 ± 0.22 | 4.969 ± 0.22 | 5.281 ± 0.21 | 0.026 |
| p-value b | 0.52 | 0.94 | 0.99 | 0.052 | ||
| BSE-150 | 4.813 ± 0.15 | 5.219 ± 0.16 | 5.344 ± 0.15 | 5.438 ± 0.14 | 5.875 ± 0.11 | <0.001 |
| p-value b | 0.010 | <0.001 | <0.001 | <0.001 | ||
| BSE-300 | 4.676 ± 0.21 | 4.941 ± 0.2 | 5.265 ± 0.17 | 5.441 ± 0.16 | 5.765 ± 0.10 | <0.001 |
| p-value b | 0.1155 | 0.002 | 0.002 | <0.001 | ||
| Total distance walked in 6 min | ||||||
| Placebo | 322.8 ± 13.4 | 321.3 ± 12.42 | 317.8 ± 11.89 | 315.6 ± 11.2 | 330 ± 11.15 | 0.18 |
| p-value b | 0.99 | 0.82 | 0.59 | 0.69 | ||
| BSE-150 | 309.4 ± 8.72 | 331.3 ± 9.3 | 341.3 ± 8.18 | 343.4 ± 7.28 | 375 ± 5.26 | <0.001 |
| p-value b | 0.004 | <0.001 | <0.001 | <0.001 | ||
| BSE-300 | 298.2 ± 11.22 | 309.9 ± 11.25 | 332.9 ± 9.86 | 345.3 ± 8.69 | 363.8 ± 6.31 | <0.001 |
| p-value b | 0.1266 | <0.001 | <0.001 | <0.001 | ||
Mean ± Standard deviations are represented. One-way repeated measure analysis of variance (RMANOVA) was computed for each group at different time points.
a
RMANOVA.
b
Post hoc analysis using Dunnett’s multiple comparisons with Day 0.