FIG 1.

Patient flow diagram. Two patients in the low-dose cohort and four patients in the high-dose cohort prematurely discontinued study treatment but completed the study (i.e., attended remaining scheduled visits and underwent prespecified testing procedures). The study began with 12 patients (of the 24 enrolled) in the low-dose cohort, followed by a second set of 12 patients in the high-dose cohort; none of the 12 patients in the high-dose cohort had participated in the low-dose phase of the study.