- If female: pelvic examination with Papanicolaou smear within previous 3 years; mammogram within previous 12 months; Chest X-ray (posteroanterior and lateral views) taken on or within the previous 3 months if known or suspected history of cardiopulmonary disease. If there is any family history of any malignant disorder that has known familial association, then the subject's current cancer status for that disorder must be investigated as per direction from the sponsor's medical monitor.