13. Subject has any other concurrent medical or social condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study (e.g., concurrent malignancy; history of unstable angina or repeated myocardial infarction; uncontrolled asthma or diabetes; unstable thyroid disease or other significant hormonal condition; frequent or uncontrolled seizure disorder; severe psychiatric disorder requiring psychotropic medication; active tuberculosis, pneumonia, or other severe infection under current treatment; lives in a country other than that of the investigative site; or has other medical or social circumstances likely to interfere with the schedule of evaluations).