Patients and study design
UC
The study described herein was approved by the Western Institutional Review Board and the UC Irvine Institutional Review Board. This study included a 5-week, open-label dose-optimization period (DOP) followed by a 2-week, randomized, crossover double-blind treatment period (DBP), with details reported previously (Cutler et al., After a 3-day washout period, all eligible patients entered the 5-week DOP, which evaluated 4 doses of d-ATS: 5, 10,15, and, 20 mg (equivalent to approved doses of 4.5 mg/9 hours, 9 mg/9 hours, 13.5 mg/9 hours, and 18 mg/9 hours, respectively) (Xelstrym Prescribing Information, 