<qa>  What is the name of the study that is a clinically significant cardiovascular, pulmonary,- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results. Subjects with any history of resolved cancer that is 5 years passed can be included. 