Table 1. Analysis of the Effect of Rintatolimod on the Primary Endpoint, Exercise Tolerance (ET).
| A. Increase in Exercise Treadmill Duration with Rintatolimod in CFS Patients (Intent-to-Treat) | |||||
| Study Interval | Mean (SD) Exercise Duration (Seconds) | Percent Increase from Baseline1 | p-value | ||
| Rintatolimod (n = 100) | Placebo (n = 108) | Rintatolimod (n = 100) | Placebo (n = 108) | ||
| Baseline | 576 (257.5) | 588 (234.4) | - | - | 0.7292 |
| Week 40 | 672 (314.1) | 616 (286.7) | 36.5 | 15.2 | 0.0473 |
| p-value4 | - | - | <0.001 | 0.198 | |
1
Mean intra-patient percent improvement.
2
Student's t-test comparing mean baseline ET between treatment groups.
3
Analysis of covariance (ANCOVA) with baseline as a covariate comparing the mean ET change from baseline within each treatment group.
4
Paired t-test comparing whether the change from baseline is equal to zero within each treatment group.
5
Probability that a difference between treatment groups exists using the chi-square test.