Table 5A.

Summary of Mixed Model for Percent Change in Mean OCS.

Parameter	Beta Estimate (Std Err)	95% CI	P-value
Intercept	−35.14 (11.74)	−59.80, −10.48	0.0078
Active–Sham Sequence (vs Sham–Active Sequence)	5.22 (13.12)	−22.74, 33.18	0.6962
Active Treatment (vs Sham Treatment)	−29.76 (10.92)	−53.04, −6.48	0.0078
Week 2 (vs Week 3)	20.73 (10.92)	−2.56, 44.01	0.0772

All Randomized Patients Non-Missing Data at Particular Visit.

Summary of Parameter (Beta) Estimates from Mixed Model.

[1] A mixed model for percent change in mean OCS assessed prior to treatment each week that includes treatment, treatment sequence, and week as fixed effects and a subject level random effect was constructed.

[2] Active Treatment (vs Sham Treatment) is a one-sided p value.