- Each subject must have participated in study 3115A1-303 and must have satisfied all of
the following criteria:
- Has completed 24 months of treatment.
- Was at least 80% compliant with study drug administration.
- Endometrial biopsy at baseline, month 6 or month 24 that were technically unacceptable
- Did not have an endometrial biopsy at all of the required timepoints (baseline, month
6, month 24)