Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPatient would not be eligible if he/she has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXCurrent alcohol or drug abuse.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPatient has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXCOHORT 1: Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXCOHORT 2: Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXSAFETY RUN-IN: Active substance abuse or psychiatric disordersXx_NEWLINE_xXRANDOMIZED PHASE II CLINICAL TRIAL: Active substance abuse or psychiatric disordersXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.Xx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the studyXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the studyXx_NEWLINE_xXHistory of alcohol abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the studyXx_NEWLINE_xXActive substance abuseXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trialXx_NEWLINE_xXPatients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPatients who have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial are not eligibleXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the studyXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with the requirements of the studyXx_NEWLINE_xXPatients with current alcohol or drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPatient has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown substance abuse or receiving concurrent treatment with non-permitted drugs.Xx_NEWLINE_xXKnown current drug or alcohol abuseXx_NEWLINE_xXHistory of active alcohol or drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXKnown current alcohol or drug abuse.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown alcohol or drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the studyXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial in the opinion of the treating providerXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXKnown alcohol or drug abuse within the last 1 year.Xx_NEWLINE_xXActive alcohol or drug abuseXx_NEWLINE_xXPatients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPatients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with adherence to the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXActive, uncontrolled psychiatric disorders or substance (drug/alcohol) abuse that interfere with patient’s safety, ability to provide informed consent, or ability to comply with the protocolXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHistory of alcohol abuse.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas a known psychiatric or substance abuse disorder(s) that would interfere with informed consent or cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial; at the time of signing informed consent is a known regular user (including \recreational use\) of any illicit drug(s) or had a recent history (within the last year) of drug or alcohol abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPsychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that could interfere with cooperation with the requirements of the protocolXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the studyXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXKnown alcohol or drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHistory of alcohol abuse.Xx_NEWLINE_xXPatients with current alcohol or drug abuseXx_NEWLINE_xXActive substance abuse or psychiatric disorders; in case, the patient falls under the lower spectrum of psychiatric disorders and is able to function well under medication, the patient could be accrued at the discretion of the physicianXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPatients with known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHistory of alcohol or other substance abuse within the last year.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPatient has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown drug or alcohol abuse;Xx_NEWLINE_xXKnown alcohol or drug abuseXx_NEWLINE_xXKnown alcohol or drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown alcohol or drug abuseXx_NEWLINE_xXKnown alcohol or drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the studyXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXKnown alcohol or drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown drug or alcohol abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown alcohol or drug abuse within the last 1 yearXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXActive alcohol or drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHistory of known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the studyXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPsychiatric illness, substance abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXActive alcohol or drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXKnown alcohol or drug abuseXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown current drug abuse or alcohol abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPsychiatric illness, substance abuse, and/or social situation that would limit compliance with study requirementsXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXSubject has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHistory suggestive of substance abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPatient has alcohol or substance abuse which, in the opinion of the investigator, would interfere with compliance or safetyXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXActive alcohol or drug abuseXx_NEWLINE_xXHistory of alcohol abuseXx_NEWLINE_xXMeet criteria for the following psychiatric and/or substance use disorders as assessed by the MINI International Neuropsychiatric Interview (MINI): items C (current manic or hypomanic episode only), I (alcohol abuse - Alcohol Addendum - past 6 months only; current alcohol dependence), J (substance abuse - Substance Abuse Addendum - past 6 months only; current substance dependence), K (current psychotic disorder or current mood disorder with psychotic features); individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the principal investigator and/or study physicianXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPatient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHistory of alcohol or other substance abuse or dependence within the year prior to registrationXx_NEWLINE_xXPatient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHistory of alcohol abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown drug or alcohol abuse.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study;Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXSubstance or alcohol abuse or dependence, within 12 months prior to screening.Xx_NEWLINE_xXKnown or suspected substance abuse or alcohol abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the studyXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown drug abuse/ alcohol abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXREGISTRATION TO TREATMENT (STEP 1): Patient must not have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXKnown psychiatric or substance abuse disorder that would interfere with the ability of the patient to comply with trial requirementsXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the trial or evaluation of the trial resultXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPatients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPast or present history of active substance abuse (drug or alcohol)Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the studyXx_NEWLINE_xXKnown or suspected active drug or alcohol abuseXx_NEWLINE_xXPatient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHistory of active substance or alcohol abuse within the last yearXx_NEWLINE_xXHistory of active substance or alcohol abuse within the last yearXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the studyXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. Is a known regular user (including \recreational use\) of any illicit drug(s) or had a recent history (within the last year) of drug or alcohol abuse.Xx_NEWLINE_xXKnown alcohol or drug abuseXx_NEWLINE_xXHistory of drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.Xx_NEWLINE_xXKnown alcohol or drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXPsychiatric disorders and substance (drug/alcohol) abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the studyXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the studyXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHistory of alcohol or substance abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHave a known history of drug abuse.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the studyXx_NEWLINE_xXKnown or suspected active drug or alcohol abuse.Xx_NEWLINE_xXKnown drug or alcohol abuseXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown alcohol or drug abuseXx_NEWLINE_xXActive alcohol or drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXNo active alcohol or drug abuseXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the studyXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPatient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown or suspected active drug or alcohol abuseXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPatients that have a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXKnown or suspected active drug or alcohol abuseXx_NEWLINE_xXKnown alcohol or drug abuseXx_NEWLINE_xXPsychiatric illness/substance abuse/social situation that would limit compliance with study requirements.Xx_NEWLINE_xXKnown or suspected active alcohol or drug abuse.Xx_NEWLINE_xXCurrent alcohol or drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that could interfere with cooperation with the requirements of the protocolXx_NEWLINE_xXPsychiatric illness/substance abuse/social situation that would limit compliance with study requirementsXx_NEWLINE_xXKnown alcohol or drug abuse.Xx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas a known psychiatric or substance abuse disorder(s) that would interfere with informed consent or cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXActive alcohol abuseXx_NEWLINE_xXKnown presence of alcohol and/or drug abuse.Xx_NEWLINE_xXKnown presence of alcohol and/or drug abuse.Xx_NEWLINE_xXKnown alcohol or drug abuse.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXDONOR: Active substance abuseXx_NEWLINE_xXActive alcohol or drug abuseXx_NEWLINE_xXKnown or suspected active drug or alcohol abuseXx_NEWLINE_xXSubject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collectionXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders.Xx_NEWLINE_xXActive substance abuseXx_NEWLINE_xXHistory of alcohol or substance abuse, unless in full remission for more than 6 months prior to start of study treatmentXx_NEWLINE_xXKnown or suspected active drug or alcohol abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown current drug or alcohol abuseXx_NEWLINE_xXKnown or suspected active drug or alcohol abuse;Xx_NEWLINE_xXActive alcohol or drug abuseXx_NEWLINE_xXKnown or suspected alcohol abuseXx_NEWLINE_xXKnown current drug or alcohol abuseXx_NEWLINE_xXSubjects may not have known current drug or alcohol abuseXx_NEWLINE_xXPsychiatric illness/substance abuse/social situation that would limit compliance with study requirements.Xx_NEWLINE_xXDonor must not have active alcohol or substance abuse within 6 months of study entry.Xx_NEWLINE_xXRecipient must have no active alcohol or substance abuse within 6 months of study entry.Xx_NEWLINE_xXKnown or suspected active alcohol or drug abuse.Xx_NEWLINE_xXHistory of drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHistory of alcohol abuseXx_NEWLINE_xXSelf-reported active alcohol or substance abuse within the last 30 daysXx_NEWLINE_xXActive substance abuse or dependenceXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown alcohol or drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHistory of substance abuse.Xx_NEWLINE_xXAre in treatment for substance abuse (e.g., illicit drugs, alcohol abuse)Xx_NEWLINE_xXHistory of substance abuseXx_NEWLINE_xXHistory of substance abuseXx_NEWLINE_xXIllicit substance abuse within the past 6 monthsXx_NEWLINE_xXHistory of substance abuseXx_NEWLINE_xXHistory of alcohol abuseXx_NEWLINE_xXAlcohol or drug abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the studyXx_NEWLINE_xXCurrent alcohol or drug abuseXx_NEWLINE_xXHistory or current diagnosis of substance abuse or dependenceXx_NEWLINE_xXCurrent documented alcohol abuse or illicit drug substance abuseXx_NEWLINE_xXActive alcohol or substance abuse issueXx_NEWLINE_xXConcurrent illness, such as known psychiatric disorders or substance abuse (i.e., average alcohol consumption of more than 3 drinks per day), which in the opinion of the investigators would compromise either the patient or the integrity of the dataXx_NEWLINE_xXConcurrent illness, such as known psychiatric disorders or substance abuse (i.e., average alcohol consumption of more than 5 drinks per day), which in the opinion of the investigators would compromise either the patient or the integrity of the dataXx_NEWLINE_xXHistory of alcohol or other substance dependence or current abuseXx_NEWLINE_xXHistory of alcohol or other substance dependence or current abuseXx_NEWLINE_xXMeet criteria for the following psychiatric and/or substance use disorders as assessed by the Mini International Neuropsychiatric Interview (MINI): items C (current manic or hypomanic episode only), I (alcohol abuse - alcohol addendum-past 6 months only; current alcohol dependence), J (substance abuse - substance abuse addendum - past 6 months only; current substance dependence), K (psychotic disorder or mood disorder with psychotic features); individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the principal investigatorXx_NEWLINE_xXOther known drug use/abuseXx_NEWLINE_xXPsychiatric conditions, social situations or substance abuse that precludes the ability of the subject to cooperate with the requirements of the trial and protocol therapyXx_NEWLINE_xXMeet criteria for the following psychiatric and/or substance use disorders as assessed by the Mini International Neuropsychiatric Interview (MINI); items C (current manic or hypomanic episode only), I (alcohol abuse-Alcohol Addendum-past 6 months only; current alcohol dependence), J (substance abuse-Substance Abuse Addendum-past 6 months only; current substance dependence), K (current/lifetime psychotic disorder or current/lifetime mood disorder with psychotic features); individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the principal investigator and/or study physicianXx_NEWLINE_xXOngoing alcohol abuseXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXWith current substance abuse and/or history of substance abuse, as per medical records or patient reportXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHistory of substance abuseXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the studyXx_NEWLINE_xXHistory of alcoholism or other substance abuseXx_NEWLINE_xXSubstance abuse within the past 2 yearsXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXPatients who are unwilling or unable to comply with the protocol or have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial are not eligibleXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown alcohol or drug abuseXx_NEWLINE_xXHas a known psychiatric and/or substance abuse disorder that would make it difficult for the participant to cooperate with the requirements of the trialXx_NEWLINE_xXKnown alcohol or drug abuseXx_NEWLINE_xXThe participant has known drug or alcohol abuse.Xx_NEWLINE_xXThe participant has known drug or alcohol abuse.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXHas a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Xx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xXHas known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trialXx_NEWLINE_xX