Fig. 1

Overview of Study Design. Visits 1 and 2 could have been combined if results from all assessments at Visit 1 were obtained at the time of Visit 1. If Visits 1 and 2 were conducted on the same day, visit procedures that were specific to Visit 2 were also conducted during Visit 1. The telephone call during the 2-week safety follow-up period was required for all patients (i.e., patients who completed the full 6 months of treatment, patients who completed less than 6 months of treatment, patients who discontinued early from the study, and patients who took at least 1 dose of study drug)