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 6 Schedule for final in-clinic evaluation of smokers

Day and suggested times	Sampling	Procedure
*181*
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; dinner
1900 h	None	Start first 24 h urine collection, monitoring of cigarette consumption and collection of filters
2100 h	None	Snack
182
0700 h	Blood	Measure BP, PR, RR and temperature; measure creatinine in serum; biomarkers and gene expression
0800 h	None	Breakfast
To be scheduled	None	Assess smoking behaviour^a
1000 h	None	Administer sensory, quality-of-life and diet and lifestyle questionnaires†
1200 h	None	Lunch
1500 h	None	Measure exhaled CO
1700 h	Saliva	Cotinine testing; dinner
1900 h	None	End first and start second 24 h urine collection, monitoring of cigarette consumption and collection of filters
2100 h	None	Snack
183
Anytime (check out)	None	Measure BP, PR, RR and temperature; physical examination; electrocardiography
0700 h	Blood	Measure creatinine in serum; biomarkers
0800 h	None	Breakfast
To be scheduled	None	Assess smoking behaviour^a
1100 h	None	Pulmonary-function test
1200 h	None	Lunch
1500 h	None	Measure exhaled CO
1700 h	Saliva	Cotinine testing; dinner
1900 h	None	End second 24 h urine collection, monitoring of cigarette consumption and collection of filters; dispense adequate commercial products of normal ISO tar yield for 7 post-study days

BP, blood pressure, PR, pulse rate, RR, respiratory rate, CO, carbon monoxide, ^aTo be performed by sponsor. †May be done on day 183.

ISSN: 1471-2458