 - Patient has intercurrent illness including, but not limited to: ongoing active or severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, myocardial infarction within 6 months, uncontrolled diabetes mellitus, chronic liver or renal disease, active upper GI tract ulceration or psychiatric illnesssocial situations that would limit compliance with study requirements. 