Cotton wool spots in qualifying eye
10. Macular star in qualifying eye 11. History of significant cardiac conduction block 12. History of cancer (except non-melanoma skin cancer) 13. Suicidal ideation or behavior in 6 months prior to baseline 14. Pregnancy, breastfeeding, or planning to become pregnant 15. Included with other study protocol simultaneously without prior approval 16. Concomitant or prior use of any other putative remyelinating therapy as determined by
investigator, including but not limited to Clemastine, Duavee, and Tamoxifen.
17. Serum creatinine > 1.5mg/dL; AST, ALT, or alkaline phosphatase > 2 times the upper
limit of normal
18. History of drug or alcohol abuse within the past year 19. Untreated B12 deficiency (as determined by B12 serological assessments and metabolites
including methylmalonic acid [MMA] and homocysteine) or untreated hypothyroidism
20. Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic,
urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal or other major diseases that in the PI's judgement may affect interpretation of study results or patient safety.
21. History of or presence of clinically significant medical illness or laboratory
abnormality that, in the opinion of the investigator would preclude participation in the study.
22. Patients whose lack of mobility exposes them to an increased risk of venous
thromboembolism
23. Patients with undiagnosed uterine bleeding 24. Patients with unknown, suspected or past history of breast cancer 25. Patients with known or suspected estrogen-dependent neoplasia 26. Patients with active or a past history of venous thromboembolism 27. Patients with active or a past history of arterial thromboembolism 28. Patients with known protein C, protein S, or antithrombin deficiency or other known
thrombophilic disorders
29. Patients with hypersensitivity (angioedema, anaphylaxis) to estrogens, bazedoxifene,
or any ingredients
30. Patients with known hepatic impairment or disease