 9. Other Exclusion Criteria: a Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subjects ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results. b Prisoners or subjects who are involuntarily incarcerated. c Subjects who are compulsorily detained for treatment of either a psychiatric or physical eg, infectious disease illness. 