 19. Any medical conditions that would impose excessive risk to the patient, such as uncontrolled hypertension systolic 150 mmHg or diastolic 100 mmHg per JNC 7 guidelines, congestive heart failure NYHA Class 2-4, uncontrolled or unstable angina, myocardial infarction within the previous 6 months, ventricular arrhythmia, infection requiring parental or oral anti-infective treatment, any altered mental status or any psychiatric condition that would interfere with understanding the informed consent, uncontrolled seizures, chronic hepatitis or cirrhosis, known human immunodeficiency virus HIV infection, known hepatitis B surface antigen HBsAg positive or uncontrolled diabetes. Note: testing for HIV infection of HBsAg is not part of the screening assessments performed by the central laboratory. 