 - Participant has a history of or current clinically significant medical illness including but not limited to cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders including any abnormal bleeding or blood dyscrasias, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results 