 - Patients with invasive malignancy other than melanoma at the time of enrollment and within 2 years of screening are excluded, except for: adequately treated i.e. with curative intent basal or squamous cell carcinoma, in situ carcinoma of the cervix, in situ ductal adenocarcinoma of the breast, in situ prostate cancer, or limited stage bladder cancer or other any other cancers from which the patient has been disease-free for at least 2 years. 