renal hepatic disease significant pulmonary cardiovascular endocrine investigator gastrointestinal metabolic 
cardiac significant clinically disease history uncontrolled dysfunction pulmonary active months 
cardiovascular significant including disease clinically uncontrolled pulmonary poorly active condition 
cardiovascular significant disease clinically uncontrolled history pulmonary active diseases months 
tolerance impair opinion investigator significant diseases treatment example trial inflammatory 
cardiac impaired function clinically significant diseases disease following including patients 
significant clinically disease history uncontrolled metabolic heart immunosuppression medical study 
morbidities active clinically disease significant compromise pulmonary uncontrolled participation condition 
uncontrolled concurrent significant compromise clinically medical severe participation neurological pulmonary 
cardiovascular history conditions disease evidence risk following uncontrolled unstable current 
significant disease interpretation affect diseases pulmonary uncontrolled concomitant results compliance