illness compliance social requirements psychiatric intercurrent situations uncontrolled limit study compliance psychological safety condition protocol study conditions psychiatric medical procedures staff medical regimens conduct history noncompliance compliance study planning non trial confound best abnormality results interfere participate laboratory duration current illness medical psychiatric interfere condition prevent opinion abnormality potentially likely illness pectoris social situations intercurrent arrhythmia uncontrolled compliance congestive limited inappropriate make judgment study investigator severe interfere patient entry increase interfere results study interpretation condition medical investigator participation opinion evaluation cooperation substance abuse disorders interfere psychiatric requirements trial known study opinion condition investigator medical study subject compromise patient participation safety