TABLE 2.
Statistical analysis of lane exceedance (count) – log(x + 1) value (intent‐to‐treat population)
|
20 mg Tasimelteon (N = 48) |
7.5 mg Zopiclone (N = 46) |
Placebo (N = 46) |
|
|---|---|---|---|
| Mean (SD) | 2.60 (1.245) | 3.11 (0.949) | 2.42 (1.072) |
| Median | 2.63 | 3.07 | 2.52 |
| Min, max | 0.0, 5.2 | 1.1, 5.9 | 0.0, 5.4 |
| LS means a | 2.57 | 3.24 | 2.44 |
| p value for period a | .7952 | ||
| p value for sequence a | .0620 | ||
| 20 mg Tasimelteon versus placebo | 7.5 mg Zopiclone versus placebo | 20 mg Tasimelteon versus 7.5 mg zopiclone | |
| Difference in LS means a | 0.13 | 0.80 | −0.66 |
| 95% CI a | (−0.12, 0.39) | (0.53, 1.06) | (−0.92, −0.41) |
| p value a | .3085 | <.0001 | <.0001 |
CI, confidence interval; LS, least square; N, number of subjects; SD, standard deviation.
a
Mixed‐effects model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points, an unstructured covariance structure, and Kenward‐Roger degrees of freedom. Estimated differences are first treatment label listed minus second treatment label.