13. Use of vitamins from Day -7 until end-of-study follow up call, and use of over-thecounter (OTC) medications, prescription medications, or herbal remedies from Day - 14 until end-of-study follow-up call. By exception, acetaminophen ≤ 1000 mg/day is permitted except within 48 hours prior to Day -1. Hormone replacement therapy (HRT) and hormonal contraception is allowed throughout the study. The Medical Monitor and Principal Investigator may allow certain OTC medications by exception if they are not likely to affect study conduct and output.