 1. Uncontrolled concurrent illness, including but not limited to: ongoing or active infection, symptomatic congestive heart failure NYHA Class III or IV, unstable angina pectoris, life-threatening cardiac arrhythmia, or psychiatric illnesssocial situations that would limit compliance with study requirements andor obscure study results. Patients with a history of myocardial infarction in the last three months are also excluded from the trial. 