 - Current smoker or smoked or used nicotine containing products within 5 years of screening, history within 5 years prior to study start or evidence of illicit drug abuse or if the investigator suspects current drug use with drug classes that include but are not limited to barbiturates, amphetamines, benzodiazepines, cocaine, opiates, cannabis or any other illicit drugs verified by urine drug screening or other reliable evidence, history or evidence of current alcohol abuse or if participant reports a regular average alcohol consumption exceeding 18 g women or 35 g men of pure alcohol per day, i.e. 1 drinkday for women or 2 drinksday for men 1 drink 150 mL of wine or 360 mL of beer or 45 mL of hard liquor within 6 months of screening 