Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed.

The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication.

Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication.

Three denominators are reported;

• excluding cycles where other birth control methods (BCMs) was used
• all complete cycles
• compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)

The pregnancy intent-to-treat cohort (PITT) consisted of subjects between the ages of 18 and 35 who were randomized to treatment and completed at least one cycle of study medication.

Safety was assessed by summarizing adverse events recorded in the patient's daily diary and reported by subjects at each study visit, and by summarizing results of examination, vital signs and clinical laboratory values.

The safety cohort consisted of all patient who took at least one dose of study medication

Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed.

The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 7 days after the date of last combination dose of study medication.

Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 7 days after the date of last combination dose of study medication.

Three denominators are reported;

• excluding cycles where other birth control methods (BCMs) was used
• all complete cycles
• compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)

The pregnancy intent-to-treat cohort (PITT) consisted of subjects between the ages of 18 and 35 who were randomized to treatment and completed at least one cycle of study medication.