7. Subjects with a recent history of or current drug or alcohol abuse who in the opinion of the Investigator should not be included. Excessive intake of alcohol within the last 6 months, defined as a regular maximum weekly intake of greater than 7 drinks for women or 14 drinks for men. One drink is defined as one pint of regular beer (5% alcohol), 200 ml of wine (12% alcohol), or 25 ml of distilled spirits (40% alcohol).