'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in their baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; body mass index (BMI) outside the eligible range; or use of drugs known to impact ovulation or pharmacokinetic (PK) of MPA (with the exception of selective cyclooxygenase-2 [COX-2] inhibitors that were taken for <5 consecutive days).

Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for <5 consecutive days). Overall number of participants analyzed= participants evaluable for this outcome measure.

Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for <5 consecutive days).

Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for <5 consecutive days).

Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for <5 consecutive days). Overall number of participants analyzed= participants evaluable for this outcome measure.

Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for <5 consecutive days). Overall number of participants analyzed= participants evaluable for this outcome measure.

Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for <5 consecutive days).

Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for <5 consecutive days). Overall number of participants analyzed= participants evaluable for this outcome measure.

Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for <5 consecutive days).

Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for <5 consecutive days).

Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for <5 consecutive days).

Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for <5 consecutive days).

Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for <5 consecutive days).

Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL.

Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.

Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL. Time to ovulation was computed as the difference in days between detection of the first post-randomization elevated progesterone and the date of treatment initiation. Median time to ovulation was derived using Kaplan-Meier estimate.

Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for <5 consecutive days).

Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.

Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.

Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.

Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.

Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.

Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.

Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.

Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.

An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Treated population included all screened participants who were enrolled and received a dose of study drug.