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Table 4 Schedule for first 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
12
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
13
0700 h Blood Measure BP, PR, RR and temperature; blood collection for 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 questionnairesb
1200 h None Lunch
1500 h None Measure exhaled CO
1700 h Saliva 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
14
0700 h Blood Measure BP, PR, RR and temperature; blood collection for creatinine in serum, biomarkers and gene expression
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 Saliva cotinine testing; dinner
1900 h None End second 24 h urine collection, monitoring of cigarette consumption and collection of filters; switch to next assigned product
2100 h None Snack
15
0700 h None Measure BP, PR, RR and temperature
0800 h None Breakfast
1000 h None Administer sensory questionnaire
1200 h None Lunch
1700 h None Dinner
1900 h None End filter collection; dispense interventional products and cigarette butt collection tins for use at home, remind participants of instructions for diet and completion of diaries
  1. BP, blood pressure, PR, pulse rate, RR, respiratory rate CO, carbon monoxide, aTo be performed by sponsor. bMay be done on day 14.
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BMC Public Health

ISSN: 1471-2458

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