 6. Has a history of drug abuse defined as any illicit drug use or a history of alcohol abuse defined as regular consumption of 5 or more units per day within 5 years prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine. Ethanol consumption within 72 hours prior to Check-in Day -1 verified by alcohol breath test Alcotest. 