- Subjects who have completed all scheduled evaluations in protocol 3115A1-303-WW.
- Completed 24 months of treatment in protocol 3115A1-303.
- Had a mammogram at the baseline visit and at the month 24 visit in protocol
3115A1-303, and both are original films that are technically acceptable for reading.
- Was at least 80% compliant with test article administration during protocol
- Had a mammogram at either baseline or month 24 during the 3115A1-303 study that was
- One or both mammograms were digitized when they were obtained during the 3115A1-303
- Had more than one mammogram at either the baseline or month 24 visit of study