10. Serious medical illness, such as cardiovascular disease [uncontrolled congestive heart failure or hypertension, active ischemic disease of the heart (angina), recent (<3 months) myocardial infarction, severe cardiac arrhythmia], bleeding disorders, obstructive or restrictive pulmonary diseases, active systemic infections requiring antibiotics, serious intercurrent illness requiring hospitalization, inflammatory bowel disorders, or significant psychiatric disease, which in the opinion of the principal investigator would prevent adequate informed consent or render study treatment unsafe or contraindicated.