- Severe, active co-morbidity, defined as follows: Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration, Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or oxygen, Hepatic insufficiency or Active liver disease resulting in clinical jaundice and/or coagulation defects, Acquired immune deficiency syndrome (AIDS) , Significant neurologic or psychiatric disorder which would impair the ability to obtain informed consent, Active uncontrolled or serious infection, active peptic ulcer disease, Any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction), Myocardial infarction within 6 months prior to registration, Congestive heart failure, unstable angina, active cardiomyopathy, cardiac arrhythmia, Skeletal muscle disease and other related reticule-endothelial diseases.