Figure 1.

Disposition of enrolled subjects.

^aIncludes 1 subject discontinued due to investigator’s decision and 1 subject discontinued due to pregnancy. In the latter case, the subject had a negative pregnancy test at Visit 1, but reported that she had a positive pregnancy test prior to Visit 2a. The subject was discontinued immediately before the scheduled Visit 2a and did not receive any test medications.

Abbreviations: ITT, intent-to-treat population; mITT, modified intent-to-treat population.