Table 10.
Parameter | Comparison | E(1) | 95% CI Low(1) | 95% CI High(1) | p-Value(2) |
---|---|---|---|---|---|
Change from baseline to week 8 | Comfort Shield vs. Control | 13.999 | 5.011 | 22.986 | 0.003 |
(1) Estimate (E) and associated 95% two-sided confidence interval (CI) of the difference between treatment group adjusted means: MMRM with the fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, the random categorical effect of center, as well as the continuous, fixed covariates of baseline and baseline-by-visit interaction. A positive estimate of the difference between treatment group adjusted means is in favour of the Comfort Shield, a negative one in disfavor of the Comfort Shield. (2) two-sided p-value associated with the test of treatment effect.