Table 4

Premarket human behaviour studies

DurationParticipants
started
Participants
completed
Switch to ‘Exclusive’ IQOS use*IQOS use category in the final study week (completed participants)
Exclusive†
IQOS use
Predominant‡
IQOS use
Combined§
IQOS+cigarettes
Predominant¶
cigarette use
Exclusive**
cigarette use
THS-PBA-07-US
 Analytical sample††6 weeks11069686.0%7.5%7.0%22.4%28.2%34.5%
 On-protocol sample‡‡6 weeks11064653.2%6.5%5.2%20.8%32.9%34.6%
WOT - Japan
 Included sample§§4 weeks71863813.2%13.6%16.1%32.3%27.7%10.2%
WOT - Italy
 Included sample§§4 weeks5715354.7%5.2%6.9%37.9%39.3%10.7%
WOT - Germany
 Included sample§§4 weeks4433777.7%8.5%11.4%27.3%24.7%28.1%
WOT - Switzerland
 Included sample§§4 weeks5164163.8%4.3%5.5%39.4%30.5%20.2%
WOT - South Korea
 Included sample§§4 weeks93684315.3%15.7%21.5%36.3%17.3%9.3%
  • *Recorded use of ≥100 HeatSticks during the study and HeatSticks comprised ≥95% of total cigarettes and HeatSticks recorded in the final week.

  • †Of cigarettes and HeatSticks recorded, HeatSticks comprised ≥95% of total.

  • ‡Of cigarettes and HeatSticks recorded, HeatSticks comprised ≥70% but <95% of the total.

  • §Of cigarettes and HeatSticks recorded, HeatSticks comprised ≥30% but <70% of the total.

  • ¶Of cigarettes and HeatSticks recorded, HeatSticks comprised ≥5% but <30% of the total.

  • **Of cigarettes and HeatSticks recorded, HeatSticks comprised <5% of the total.

  • ††Analytical sample restricted to a subset of enrolled participants who met inclusion criteria and recorded ≥1 cigarette use during the 1-week baseline run-in period and ≥1 IQOS HeatStick use during the 6-week observation period (excludes 262 of 1368 initially enrolled participants).

  • ‡‡Per-protocol sample restricted to participants who also documented tobacco use 39 days of the 42-day observation period and did not report IQOS use exceeding number of HeatSticks supplied by >5% or 20 units.

  • §§Sample restricted to participants who completed 26 of the 28 daily tobacco use diary entries (ranges from 81% to 93% of participants who were eligible to begin the 4-week studies based on willingness to use IQOS).

  • n/a=not applicable; nr, not reported; WOT, whole offer test.