A single-blinded, single-centre, controlled study in healthy adult smokers to identify the effects of a reduced toxicant prototype cigarette on biomarkers of exposure and of biological effect versus commercial cigarettes

Table 5 Schedules for second, third and fourth in-clinic evaluations of smokers

Days and suggested times	Sampling	Procedure
45, 76, 108
1700 h (check in)	Blood, urine	Measure BP, PR, RR and temperature; abbreviated physical examination and medical history; illicit drug, alcohol and cotinine testing; pregnancy testing; collection of diary and cigarette butts; clinical laboratory tests; electrocardiography; lung- function tests; dinner
1900 h	None	Start 24 h urine collection, monitoring of cigarette consumption and collection of filters
2100 h	None	Snack
46, 77, 109
0700 h	Blood	Measure BP, PR, RR and temperature; measure creatinine in serum; biomarkers and gene expression
0800 h	None	Breakfast
1000 h	None	Administer sensory questionnaire; administer quality-of-life and diet and lifestyle questionnaires^a
1200 h	None	Lunch
1500 h	None	Measure exhaled CO
1700 h	Saliva	Cotinine testing; dinner
1900 h	None	End 24 h urine collection, monitoring of cigarette consumption and collection of filters; dispense interventional products and cigarette butt collection tins for use at home, remind participants of instructions for diet and completion of diaries

BP, blood pressure, PR, pulse rate, RR, respiratory rate, CO, carbon monoxide, ^aOn day 108–109 visit only; may be conducted on either day.

ISSN: 1471-2458