 - Other significant non-pulmonary co-morbidities such as: coronary artery disease, peripheral vascular disease, cerebrovascular disease, congestive heart failure with an ejection fraction 50, liver disease or elevated liver enzymes at baseline, malignancy excluding non-melanoma skin cancers, AIDS, renal failure with serum creatinine 3.0, or disorders requiring steroid treatment such as vasculitis, lupus, rheumatoid arthritis 