 - Subject has a history of substance or alcohol use disorder excluding caffeine within the 12 months prior to screening, as defined by the DSM 5 criteria, or is currently using tobacco or other nicotine-containing products, or has a positive urine drug screen UDS or breath alcohol test at screening. Note: Subjects with a positive UDS may be allowed to continue in the study, provided that the investigator determines that the positive test is as a result of taking prescription medicines as prescribed. 