condition compromise opinion situation protocol investigator aes underlying medical assessment 
safety interfere opinion investigator compromise illness evaluation drug condition dysfunction 
unacceptably places toxicities high risk condition opinion medical investigator patient 
patient cognitive information compromise complete psychiatric comply study conditions ability 
tolerate compromise significant ability patients therapy opinion medical illness illnesses 
compromise safety investigator opinion condition abnormality patient medical ability study 
performing subject meeting prevent compromise study opinion requirements condition investigator 
successful psychological compromise safety opinion unstable participation conditions medical investigator 
threatening dysfunction safety compromise outcomes organ life undue illness opinion 
objectives compromise opinion investigator condition study medical protocol nonmalignant sponsor