Figure 1.

Study CONSORT diagram (adapted from Shah, et al.¹²). *The reasons 54 of 724 enrolled patients were not randomized or treated were previously reported.^{12 †}165 patients received 100 mg once daily and 1 received 50 mg twice daily. ^‡166 patients were randomized to 50 mg twice daily and 1 was randomized to 100 mg once daily.