Figure 1.

Figure 2.

Comparison of ADC and MLE among the three consumable variants_a
| Parameter | Variant 1 comparison | Variant 2 comparison | ||||||
|---|---|---|---|---|---|---|---|---|
| Base | Variant | Difference (variant - base) | Statistical equivalenceb | Base | Variant | Difference (variant - base) | Statistical equivalenceb | |
| ADC study product (sticks/day)c | 4.5 ± 3.8 | 4.6 ± 3.8 | 0.10 | – | 4.5 ± 3.8 | 4.6 ± 4.0 | 0.07 | – |
| Total ADC (sticks/day)d | 12.6 ± 6.0 | 12.7 ± 6.0 | 0.03 | – | 12.6 ± 6.0 | 12.0 ± 5.5 | −0.69 | – |
| MLE to NFDPM (mg/stick) | 4.71 ± 1.86 | 5.30 ± 2.52 | 0.59 | – | 4.71 ± 1.86 | 4.59 ± 3.14 | −0.12 | – |
| MLE to nicotine (mg/stick) | 0.30 ± 0.12 | 0.30 ± 0.14 | 0.007 | – | 0.30 ± 0.12 | 0.41 ± 0.28 | 0.112 | Not equivalent (90% CI: 1.05, 1.34) |
| MLE to NFDPM (mg/day) | 22.2 ± 21.5 | 27.2 ± 33.1 | 5.00 | Equivalent (90% CI: 0.93, 1.23) | 22.2 ± 21.5 | 22.4 ± 28.7 | 0.21 | – |
| MLE to nicotine (mg/day) | 1.40 ± 1.36 | 1.56 ± 1.91 | 0,159 | – | 1.40 ± 1.36 | 2.00 ± 2.57 | 0.597 | Not equivalent (90% CI: 1.03, 1.48) |
Study design_
| Study day | Study stage | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | |
| Visit 1: product/consumption diary allocation | |||||||||||||
| Home placement 1 | |||||||||||||
| Visit 2: puffing topography & product allocation | |||||||||||||
| Home placement 2 | |||||||||||||
| Visit 3: puffing topography & product allocation | |||||||||||||
| Home placement 3 | |||||||||||||
| Visit 4: puffing topography measurements | |||||||||||||
Percentage reduction in nine toxicants relative to cigarette smoke_a
| TobReg toxicant | Base product | Variant 1 | Variant 2 |
|---|---|---|---|
| CO | 99.76 | 99.55 | 99.90 |
| Formaldehyde | 93.92 | 95.60 | 96.32 |
| Acetaldehyde | 94.96 | 94.16 | 96.37 |
| Acrolein | 98.59 | 98.92 | 98.66 |
| 1,3-Butadiene | 99.99 | 99.99 | 99.99 |
| Benzene | 99.95 | 99.90 | 99.95 |
| Benzo[a]pyrene | 97.72 | 98.00 | 98.92 |
| NNN | 90.61 | 93.74 | 93.72 |
| NNK | 97.65 | 98.17 | 98.24 |
| Overall reduction | 97.02 | 97.56 | 97.93 |
Comparison of puffing topography data among the three consumable variants_a
| Parameter | Variant 1 comparison | Variant 2 comparison | ||||||
|---|---|---|---|---|---|---|---|---|
| Base | Variant | Difference (variant - base) | Statistical equivalenceb | Base | Variant | Difference (variant - base) | Statistical equivalenceb | |
| Puff number | 15.9 ± 8.4 | 16.4 ± 8.5 | 0.53 | – | 15.9 ± 8.4 | 14.8 ± 8.3 | −1.05 | Equivalent (90% CI: 0.86, 0.98) |
| Puff volume (mL) | 58.9 ± 31.7 | 63.4 ± 31.9 | 4.45 | Equivalent (90% CI: 1.01, 1.12) | 58.9 ± 31.7 | 58.8 ± 22.9 | −0.15 | – |
| Puff duration (s) | 2.0 ± 0.9 | 2.0 ± 0.9 | 0.08 | – | 2.0 ± 0.9 | 1.8 ± 0.7 | −0.21 | Equivalent (90% CI: 0.86, 0.93) |
| Puff interval (s) | 10.0 ± 4.8 | 9.7 ± 5.0 | −0.37 | – | 10.0 ± 4.8 | 10.0 ± 5.6 | −0.03 | – |
| Effort (mm WGs) | 500 ± 329 | 526 ± 314 | 26.2 | Equivalent (90% CI: 0.99, 1.15) | 500 ± 329 | 437 ± 279 | −63.4 | Not equivalent (90% CI: 0.80, 0.94) |
Comparison of other aerosol constituents among the study products_a
| Smoke constituent | Base product | Variant 1 | Variant 2 |
|---|---|---|---|
| Nicotine (mg/stick) | 0.46 ± 0.04 | 0.38 ± 0.03 | 0.55 ± 0.03 |
| NFDPM (mg/stick) | 13.50 ± 1.20 | 11.00 ± 0.50 | 11.10 ± 0.40 |
| Water (mg/stick) | 12.10 ± 1.00 | 15.74 ± 0.44 | 12.80 ± 0.40 |
| Glycerol (mg/stick) | 3.02 ± 0.25 | 1.94 ± 0.35 | 2.74 ± 0.19 |
Comparison of ADC and MLE for the base product among three different studies_a
| Country | MLE to NFDPM (mg/stick) | MLE to nicotine (mg/stick) | ADC study product (sticks/day)b | Total ADC (sticks/day)c | Reference |
|---|---|---|---|---|---|
| Japan | |||||
| Smokers (n = 52) | 5.2 ± 3.4 | 0.3 ± 0.2 | 10.3 ± 5.5 | 12.1 ± 5.5 | (23) |
| HTP users (n = 52) | 5.0 ± 3.1 | 0.3 ± 0.1 | 8.6 ± 4.6 | 11.2 ± 6.2 | |
| Italy | |||||
| Smokers (n = 52) | 4.7 ± 2.9 | 0.3 ± 0.2 | 7.0 ± 5.5 | 11.6 ± 5.7 | (24) |
| UK | |||||
| Smokers (n = 70) | 4.7 ± 1.9 | 0.3 ± 0.1 | 4.5 ± 3.8 | 12.6 ± 6.0 | This study |