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Table 7 Schedule for in-clinic evaluations of ex-smoker and never-smoker groups

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

1, 78, 162

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; dinner

1900 h

None

Start first 24 h urine collection

2100 h

None

Snack

2, 79, 163

0700 h

Blood

Measure BP, PR, RR and temperature; measure creatinine in serum; biomarkers and gene expressiona

0800 h

None

Breakfast

1000 h

None

Administer quality of life and diet and lifestyle questionnairesb

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

2100 h

None

Snack

3, 80, 164

0700 h

Blood

Measure creatinine in serum; biomarkers

0800 h

None

Breakfast

1000 h

None

Administer quality of life and

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

164 (check out)

Any time

Blood, urine

Measure BP, PR, RR and temperature; physical examination; electrocardiography; clinical laboratory tests

  1. aNot on day 79. bNot during visit on days 1–3; may be performed on day 79 or 80 and on day 163 or 164.