- Patient must not have an uncontrolled intercurrent illness within the 6 months prior to study entry including, but not limited to, ongoing or active infection, Class III or IV congestive heart failure (as defined by the New York Heart Association (NYHA)), unstable angina pectoris, cardiac arrhythmia, myocardial infarction, cardiac angioplasty or stenting, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, or psychiatric illness/social situations that would limit compliance with study requirements.