Table 2. Mean/Median Baseline and Mean/Median Change from Baseline in Exercise Treadmill Duration (seconds) at Week 24 (Stage 2) (ITT Population).
| Treatment Cohorts | ||||
| Prior Double-Blinded Randomized Treatment (Stage 1)↓Double-Blinded Cross-over Treatment (Stage 2) | ||||
| Exercise Tolerance (ET) Test Parameter | Rintatolimod (Stage 1)↓Rintatolimod (Stage 2)(n = 72) | Placebo (Stage 1)↓Rintatolimod (Stage 2)(n = 90) | ||
| Mean (SD) | Median | Mean (SD) | Median | |
| Baseline ET (seconds)1 | 706 (308) | 726 | 626 (291) | 638 |
| ET at End of Stage 2 (seconds) | 696 (323) | 732 | 669 (288) | 665 |
| ET Difference (seconds) | −10.4 (160.36) | 14.0 | 43.1 (198.26) | 46.0 |
| Percent ET Improvement2 | 22.9 | 1.7 | 39.0 | 8.9 |
| p-value3 | 0.58 | 0.69 | 0.04 | 0.02 |
1
Baseline of Stage 2 is the last non-missing Stage 1 value (last observation carried forward [LOCF]).
2
Mean intra-patient percent improvement.
3
p-value for the mean is from a paired t-test; p-value for the median is from the Wilcoxon signed rank test.