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Table 3 Schedule for baseline study period (Days −1 to 2)

From: A randomised, controlled, two-Centre open-label study in healthy Japanese subjects to evaluate the effect on biomarkers of exposure of switching from a conventional cigarette to a tobacco heating product

Day

Start of Procedure

Procedure

-1

12:00–19:00

Admission procedures: medical history, supine BP, PR, RR, axillary body temperature, abbreviated physical examination, lung function test, drug screen, alcohol breath test, urine cotinine test, exhaled CO test, urine pregnancy test for females, product test, dinner

19:00–20:00

Start of urine collection, start of monitoring conventional cigarette consumption

20:00–22:00

Snack

00:00

Designated smoking room closed

1

06:00

Designated smoking room opened for use

06:00–09:00

Breakfast

12:00–14:00

Lunch

16:30–17:30a

Exhaled CO assessment

18:00–19:00

Dinner

19:00–20:00b

End of first 24-h urine and cigarette use monitoring, start of second 24-h urine and cigarette use monitoring

20:00–22:00

Snack

00:00

Designated smoking room closed

2

06:00

Designated smoking room opened for use

06:00–09:00

Breakfast

12:00–14:00

Lunch

15:30–16:30c

Blood sample collection for WBC

16:30–17:30a

Exhaled CO assessment

18:00–19:00

Dinner

  1. BP blood pressure, CO carbon monoxide, PR pulse rate RR respiration rate, WBC white blood cells. aExhaled CO assessments for individual subjects should be taken at the same time on each sampling day. bEnd of 24-h urine collection needs to be time-matched to the start of 24-h urine collection for each individual subject. cTime of blood sampling for WBC for individual subjects should be taken at the same time on each sampling day