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Table 6 Schedule for final in-clinic evaluation of smokers

From: 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

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