Fig. 2.

Participant flow diagram of the AMPOWER study.

All enrolled women were included in the ITT population. Safety population included women in the ITT population who used the study drug at least once throughout the study. The mITT population included women from the ITT population who had at least one qualifying cycle or who became pregnant with a conception date between enrollment and < 8 days after final study drug use.

^aScreen failures include > 550 women in screening at the time enrollment target was met.

^bThere were 10 women who enrolled in the study more than once; only their first enrollment was counted. Excludes women who had a pregnancy detected after being enrolled but the pregnancy was determined to have started before enrollment date. Women with cycles with backup emergency contraception are excluded unless they became pregnant while in the study.

^cThere were 198 “early completers” who had completed at least six study cycles but were among 252 women inadvertently scheduled for their final study visit before study end.