Duration | Participants 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 weeks | 1106 | 968 | 6.0% | 7.5% | 7.0% | 22.4% | 28.2% | 34.5% |
On-protocol sample‡‡ | 6 weeks | 1106 | 465 | 3.2% | 6.5% | 5.2% | 20.8% | 32.9% | 34.6% |
WOT - Japan | |||||||||
Included sample§§ | 4 weeks | 718 | 638 | 13.2% | 13.6% | 16.1% | 32.3% | 27.7% | 10.2% |
WOT - Italy | |||||||||
Included sample§§ | 4 weeks | 571 | 535 | 4.7% | 5.2% | 6.9% | 37.9% | 39.3% | 10.7% |
WOT - Germany | |||||||||
Included sample§§ | 4 weeks | 443 | 377 | 7.7% | 8.5% | 11.4% | 27.3% | 24.7% | 28.1% |
WOT - Switzerland | |||||||||
Included sample§§ | 4 weeks | 516 | 416 | 3.8% | 4.3% | 5.5% | 39.4% | 30.5% | 20.2% |
WOT - South Korea | |||||||||
Included sample§§ | 4 weeks | 936 | 843 | 15.3% | 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.