 5. Uncontrolled intercurrent illness or serious medical conditions including, but not limited to: Clinically significant, uncontrolled, major cardiac, respiratory, renal, hepatic, gastrointestinal, or hematologic disease; Active uncontrolled infection; Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device; No myocardial infarction within 3 months of registration; Symptomatic inflammatory bowel disease with uncontrolled diarrhea 