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Table 4 Schedule for exposure periods (Day 2 evening – Day7)

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

2

19:00–20:00 c

End of second 24-h urine and product use monitoring, start of third 24-h urine and product use monitoring.

Switch to next assigned product (Groups A to E) or cessation (Group F)

20:00–22:00

Snack

00:00

Designated smoking room closed

3, 4, 5, 6

06:00

Designated smoking room opened for use

06:00–09:00

Breakfast

12:00–14:00

Lunch

15:30–16:30a

Blood sample collection for WBC (Day 5 only)

16:30–17:30b

Exhaled CO assessment

18:00–19:00

Dinner

19:00–20:00c

End of 24-h urine and product use monitoring, start of next 24-h urine and product use monitoring

20:00–22:00

Snack

00:00

Designated smoking room closed

7

06:00

Designated smoking room opened for use

06:00–09:00

Breakfast

12:00–14:00

Lunch

15:30–16:30a

Blood sample collection for WBC

16:30–17:30b

Exhaled CO assessment

18:00–19:00

Dinner

19:00–20:00c

End of 24-h urine and product use monitoring

End of product use Groups A to E

  1. CO carbon monoxide, WBC white blood cells. aTime of blood sampling for WBC for individual subjects should be taken at the same time on each sampling day. bExhaled CO assessments for individual subjects should be taken at the same time on each sampling day. cEnd of 24-h urine collection needs to be time-matched to the start of 24-h urine collection for each individual subject