 12. Any concurrent or previous malignancy within 5 years prior to enrollment except for basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasivein-situ neoplasm, all of which must have been adequately and radically treated. A subject with previous history of invasive malignancy other than adequately and radically treated basal or squamous skin cancer is eligible provided that she has been disease free for more than 5 years. 