Table 9.

Pain OSDI subscore: multivariate analysis on change from baseline to week 8—mixed-effects model for repeated measures—PPS population (n = 84)—n used = 84.

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	14.503	5.517	23.49	0.002

⁽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 disfavour of the Comfort Shield. ⁽²⁾ two-sided p-value associated with the test of treatment effect.