- Other Concurrent Conditions/Diseases: Any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbates during the study. The list of conditions/diseases that will result in exclusion if determined to be clinically significant includes, but is not limited to: cardiac arrhythmia; congestive heart failure; coronary artery disease; Addison's disease; diabetes mellitus; dyspnea; uncontrolled hypertension; hematological, hepatic, neurological, thyroid, peptic ulcer, or renal disease; immunologic compromise; current malignancy; or tuberculosis.