4. Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac disease NYHA class III or IV, unstable angina pectoris, unstable cardiac arrythmia or tachycardia (heart rate > 100 beats/minute), poorly controlled hypertension (systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg) or psychiatric illness/ social situations that would limit compliance with the study requirements are excluded.