 3. a mammogram that shows no sign of significant disease can be performed within previous 6 months prior to initial dose of study medication. Subjects must have a BI-RADS 1 or 2 to enroll in the study. An incomplete mammogram result, i.e. BI-RADS 0, is not acceptable. The site must obtain a copy of the official report for the subjects study file, and it must be verified that the mammogram itself is available if needed for additional assessment. 