 7. Subjects with history of other malignancies within the preceding 5 years except for subjects with non-melanoma skin cancers, cervical intra-epithelial neoplasia, prostate cancer Gleason 6 and Prostate Specific Antigen PSA 10 ngmL, radically excised lobular breast carcinoma in situ or ductal breast carcinoma in situ 15 mm unless they have undergone potentially curative therapy and have had no evidence of disease for 3 years ie, 5 years since diagnosis, no treatment or symptoms of disease for the last 3 years. 