40 mg 80 mg Placebo Total
Number of subjects Screened 32
Screen Failures 7
Not Randomized 2
Randomized 9 8 6 23
Randomized and not taken IMP 0 0 0 0
Randomized and taken IMP 9 (100%) 8 (100%) 6 (100%) 23 (100%)
Study completion 9 (100%) 7 (87.5%) 6 (100%) 22 (95.7%)
Withdrawn 0 1 (12.5%) 0 1 (4.3%)
Replacement subjects 0 0 0 0
Analysis sets Full analysis set (FAS) 9 (100%) 8 (100%) 6 (100%) 23 (100%)
Per-protocol analysis set (PPAS) 9 (100%) 8 (100%) 6 (100%) 23 (100%)