3. The participant has uncontrolled, clinically significant neurologic (e.g., migraines not well controlled, narcolepsy, previous head injury with loss of consciousness, or seizures), osteoporosis, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.