Inclusion Criteria

1. Each subject must have participated or is currently participating in study 3068A1
301, and must satisfy all of the following criteria

2. Has completed 24 months of treatment.

3. Had a mammogram at the baseline visit and at the month 24 visit, and both are
original films that are technically acceptable for reading.

4. Was less than or equal to 62 years of age at the time of study randomization in the
primary study.

5. Was at least 80% compliant with test article administration.

6. Did not take any medications 6 months prior to screening in the primary study or
during the first 24 months of the study that could cause a change in breast density.

7. Was enrolled at a site that has at least 4 subjects meeting all of the above
inclusion criteria.

8. Was enrolled at a clinical site that is still participating in the primary study.