Is a regular user as determined by investigator judgment (including \recreational use\) of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol), at the time of signing informed consent. Is a regular user of any illicit drugs or had a recent history of substance abuse Is, at the time of signing informed consent, a regular user (including \recreational use\) of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol). Has 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 abuse Is, at the time of signing informed consent, a regular user (including recreational use) of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol) Patients who are at the time of signing informed consent, a regular user of any illicit drugs, substance abuser or who have a recent history of drug or alcohol abuse Regular user (including \recreational use\) of any illicit drugs or recent history (within the last year) of substance abuse (including alcohol) Patient is, at the time of signing informed consent, a regular user (including illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol) Patient is, at the time of signing informed consent, a regular user of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse Patient is, at the time of signing informed consent, a regular user (including \recreational use\) of any illicit drugs, substance abuse or had a recent history (within the last year) of drug or alcohol abuse Has 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. Is a regular user (including \recreational use\) of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol). Is, at the time of signing informed consent, a regular user (including \recreational use\) of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol) Patient is, at the time of signing informed consent, a regular user (including recreational use) of any illicit drugs or other substance abuse (including alcohol) that could potentially interfere with adherence to study procedures or requirements Patient is, at the time of signing informed consent, a regular user (including recreational use) of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol) Is a regular user of any illicit drugs or had a recent history of substance abuse Is currently a user of any recreational or illicit drugs (including marijuana) or has current evidence of drug or alcohol abuse or dependence Is a user of recreational or illicit drugs or has a recent history (<= year) of drug or alcohol abuse or dependence Is a regular user (including recreational use) of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse