Figure 1

Enrollment, patient disposition, and baseline characteristics. Of the 303 patients originally randomized to the study, 295 comprised the ITT population and 258 entered the subsequent 74-week assessment period (ITT population). Forty-two patients withdrew during the 74-week open-ended assessment period, resulting in a completer population of n = 216. The disposition and demographic characteristics of the 30-week and 52-week populations have been published previously [25, 26].