 - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure New York Heart Association class II, unstable angina pectoris defined as anginal symptoms at rest, new-onset angina within 3 months before study treatment initiation, or myocardial infarction within 6 months before study treatment initiation, cardiac arrhythmia which require anti-arrhythmic therapy other than beta blockers or digoxin, active coronary artery disease, or psychiatric illnesssocial situations that would limit compliance with study requirements 