Study Evaluating Changes In Mammographic Breast Density

• Drug: BZA 20 mg/CE 0.45 mg
  
  There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
• Drug: BZA 20 mg/CE 0.625 mg
  
  There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
• Drug: Raloxifene 60 mg
  
  There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as raloxifene tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
• Drug: Placebo
  
  There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as placebo capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.

• 1
  
  Intervention: Drug: BZA 20 mg/CE 0.45 mg
• 2
  
  Intervention: Drug: BZA 20 mg/CE 0.625 mg
• 3
  
  Intervention: Drug: Raloxifene 60 mg
• 4
  
  Intervention: Drug: Placebo

Inclusion Criteria:

• 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 3115A1-303.

Exclusion Criteria:

• Had a mammogram at either baseline or month 24 during the 3115A1-303 study that was technically unsatisfactory.
• One or both mammograms were digitized when they were obtained during the 3115A1-303 study.
• Had more than one mammogram at either the baseline or month 24 visit of study 3115A1-303.