10. Clinically relevant active infection or serious co-morbid medical conditions such as recent (</6 months) MI, unstable angina, difficult to control CHF, uncontrolled HTN, difficult to control cardiac arrhythmias, COPD or chronic restrictive pulmonary disease, and cirrhosis. Examples of uncontrolled HTN and difficult to control cardiac arrhythmias include situations in which patients still have the problem while on medication or patients who have required > two medication changes in the last 6 months in order to control the problem, or cardiac patients with a NYHA classification of > Class II.