FIGURE 1.

Patient disposition— ^aThe 4 patients who did not start treatment are included in the breakdown of the patients who discontinued from the ATP. ^bOne patient discontinued treatment because of an AE on Day 112; the patient was observed until AE resolution on Day 191. ^cThree discontiunued because of pharmacy access issues, and one because of a move away from the study site. dCompleted PTP describes completion of the 104-week period of follow-up visits.

AE: adverse event; ATP: active treatment period; ITT: intention-to-treat; PP: per-protocol; PTP: post-treatment period