 9. Patients with significant atherosclerotic disease, as defined by: a Myocardial infarction within 6 months prior to enrollment or has New York Heart Association NYHA Class III or IV heart failure See Appendix 5 uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.; b Symptomatic congestive heart failure.; c Claudication limiting activity and ; d History of cerebrovascular events within the last year including TIA.; e Unstable angina. 