Study Design
lethargy, bradycardia
EVENT
This study was a 12-week, double-blind, placebo-controlled, parallel-group randomized clinical trial of a fixed dose of mifepristone in 5 VA outpatient clinics, conducted from November 19, 2012 (accrual started), through November 16, 2016 (final follow-up). The study was approved by each site’s institutional review board, conducted per good clinical practice guidelines, and monitored by an independent data monitoring committee. Written informed consent was obtained from every participant before enrollment. A complete list of the work group members can be found in the eAppendix in This study was initially a 3-arm study, but the 1200-mg dose arm was removed after an unanticipated event (lethargy and bradycardia). Following a pause and review by the data monitoring committee, institutional review boards (eTable 3 in 