 - Have any of the following conditions that are judged by the investigator to be clinically significant andor affect the subjects ability to participate in the clinical trial: impaired hepatic function including alcohol related liver disease or cirrhosis; history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts; any systemic infection hematological, hepatic, renal, endocrine except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism; gastrointestinal disease; malignancy excluding basal cell carcinoma; current neuropsychological condition with or without drug therapy 