 - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure New York Association class II, III, or IV, angina pectoris requiring nitrate therapy, recent myocardial infarction the last 6 months, cardiac arrhythmia, history of cerebrovascular accident CVA within 6 months, hypertension defined as blood pressure of 160 mmHg systolic andor 90 mmHg diastolic on medication history of peripheral vascular disease, or psychiatric illnesssocial situations that would limit compliance with study requirements 