19. *Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, moderate or severe hepatic impairment (according to Child-Pugh classification), an extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) or any psychiatric disorder that prohibits obtaining informed consent.