Fig. 1

Patient disposition and flow. AE = adverse event; PK = pharmacokinetic. aFive patients discontinued due to treatment emergent AEs leading to study drug discontinuation, 1 patient withdrew due to a treatment emergent AE during the washout period, and 1 withdrew due to a non-treatment-emergent AE; bpatient had a positive drug screen test for cocaine; cpatient did not meet stability/variability criteria