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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.