Cohort 1 Cohort 2 Total
Number of subjects Screened 23
Screen Failures 3
Not Randomized 3
Randomized 9 8 17
Randomized and not taken IMP 0 0 0
Randomized and taken IMP 9 (100%) 8 (100%) 17 (100%)
Study completion 8 (88.9%) 8 (100%) 16 (94.1%)
Withdrawn 1 (11.1%) 0 1 (5.9%)
Replacement subjects 1 (11.1%) 0 1 (5.9%)
Analysis sets Full analysis set (FAS) 9 (100%) 8 (100%) 17 (100%)
Per-protocol analysis set (PPAS) 9 (100%) 8 (100%) 17 (100%)