The patient has an ongoing or active psychiatric illness or social situation that would limited compliance with study requirements Psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness/social situation that would limit compliance with study requirements; Psychiatric illness or social situation which in the opinion of the Investigator would limit compliance with trial requirements. Active psychiatric illness/social situations that would limit compliance with protocol requirements Patients with a psychiatric illness, other condition or significant medical illness, or social situation which, in the investigator’s opinion, would limit compliance or ability to comply with study requirements are NOT eligible for participation History of psychiatric illness or social situations that would limit compliance with study requirements Patients with severe psychiatric illness/social situations that would limit compliance with study requirements in the judgment of study investigator Uncontrolled psychiatric illness or social situations that would limit compliance with study requirements would exclude the participant Known intercurrent illness or psychiatric illness/social situations that will limit compliance with study requirements Must not have a psychiatric illness, other significant medical illness, or social situation which, in the investigator’s opinion, would limit compliance or ability to comply with study requirements Psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements. Psychiatric illness/social situation that would limit compliance with study requirements. EXCLUSION - PARTICIPANT: Psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness/social situations that would limit compliance with study requirements. Psychiatric illness, social situation, or geographical situation that preclude informed consent or limit compliance. Psychiatric/social situations that would limit compliance with study requirements Psychiatric illness/social situation that would limit ability to provide informed consent Current psychiatric illness/social situations that would limit compliance with study requirements Uncontrolled psychiatric illness that would limit compliance with requirements Have a psychiatric illness/social situation that would limit compliance with study requirements. Any psychiatric illness or social situations that would limit compliance with study requirements Presence of a psychiatric illness or social situation that would limit compliance with study requirements A psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and/or medical record Psychiatric illness/social situations that would interfere with compliance with study requirements History of psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent History of psychiatric illness or social situations that would limit compliance with study requirements Psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness or social situation that would limit compliance with study requirements Social situations or circumstances that would limit compliance with study requirements Psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness/social situations that would limit consenting and compliance with study requirements Psychiatric illness or social situation that would limit the patient’s ability to tolerate and/or comply with study requirements Psychiatric illness/social situations that would interfere with compliance with study requirements Psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness/social situations that would limit compliance with study requirements Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness/social situation that would limit compliance with study requirements Psychiatric illness, substance abuse, and/or social situation that would limit compliance with study requirements Psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness or social situation that would limit the patient's ability to comply with study requirements Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements Psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness/social situations that would limit compliance with study requirements Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements Patients with psychiatric illness or social situations that would limit compliance with study requirements Subject has psychiatric illness or social situations that would preclude study compliance. Psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent Psychiatric illness/social situations that would limit study compliance Psychiatric illness/social situations that would limit compliance with study requirements; Psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements. Have psychiatric illness that would limit compliance with study requirements Psychiatric illness, other significant medical illness, or social situation which, in the investigator’s opinion, would limit compliance or ability to comply with study requirements Medical or psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness, other significant medical illness, or social situation which, in the investigator's opinion, would limit compliance or ability to comply with study requirements Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible Psychiatric illness/social situations that would limit compliance with study requirements. Subjects has psychiatric illness/social situations that in the opinion of the investigator would limit compliance with study requirements; Clinically significant psychiatric illness/social situations that would limit compliance with study requirements. No psychiatric illness/social situation that would limit compliance Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements. Psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness/social situation that would limit compliance with study requirements Psychiatric illness/social situations that would limit compliance with study requirements History of psychiatric illness or social situations that would limit compliance with study requirements Psychiatric illness/social situation that would limit compliance with study requirements. Psychiatric illness/social situations that would limit compliance with study requirements Participant has evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that would, in the investigator’s judgment, limit compliance with study requirements Uncontrolled psychiatric illness that would limit compliance with study requirements Severe concurrent illness or psychiatric illness/social situation that would limit compliance with study requirements. Psychiatric illness/substance abuse/social situation that would limit compliance with study requirements. Psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit compliance with study requirements. Patient must not have any life-threatening comorbid illnesses e.g. stroke with major sequelae or myocardial infarction/unstable angina within the preceding 3 months or psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness/social situation that would limit compliance with study requirements. Active psychiatric illness/social situations that would limit compliance with protocol requirements Psychiatric illness or social situation that would limit the patient's ability to comply with study requirements Psychiatric illness/substance abuse/social situation that would limit compliance with study requirements Psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent Patients must not have clinically significant psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness/social situation that would limit study compliance History of psychiatric illness or social situations that would limit compliance with study requirements 13. Psychiatric illness or social situations that would limit compliance with study requirements. Physical or psychiatric illness/social situations that in the estimation of the investigator would limit compliance with study requirements or place the participant at high risk of toxicity or non-compliance Psychiatric illness/social situation that would limit compliance with study requirements. Patients with psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness or social situation that would limit compliance with trial requirements Psychiatric illness/social situations that would limit compliance with study requirements Participants with serious psychiatric illness or social situations which would limit adherence to study requirements Active psychiatric illnesses/social situations that would limit compliance with protocol requirements Psychiatric illness/social situation that would limit compliance with study requirements; Uncontrolled psychiatric illness that would limit compliance with requirements Psychiatric illness/substance abuse/social situation that would limit compliance with study requirements. Psychiatric illness or social situations that would limit compliance with study requirements Patient with psychiatric illness or social situations that would limit compliance with treatment or adequate informed consent Psychiatric illness/social situations that would limit compliance with study requirements including but not limited to a history of schizophrenia, psychosis or substance abuse Psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness/social situations that would limit compliance with study requirements Participants with psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness/social situations that would limit compliance with study requirements Psychiatric illness (e.g., diagnosed schizophrenia or documented dementia) that would limit compliance with study requirements. Psychiatric illness/social situations that would interfere with compliance with study requirements Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements