Table 2.
Between-group statistical analysis of change from baseline in BoE and BoPH in the CEVal-compliant per-protocol population
| Biomarker (units) | Groupa | Nb | Day | LSc mean or GLSd mean ratio compared to baselinee | Difference between groups (CI)e,f | p valueg |
|---|---|---|---|---|---|---|
| Total NNALe,h (ng/24 h) | A | 55 | 90 | 0.89 | 0.50 (0.33, 0.75) | < 0.0001 |
| B | 97 | 0.44 | ||||
| Total NNNe,i (ng/24 h) | A | 55 | 90 | 0.84 | 0.51 (0.24, 1.10) | 0.0025 |
| B | 97 | 0.43 | ||||
| Total NNNe,i (ng/24 h) | A | 53 | 180 | 0.97 | 0.64 (0.37, 1.10) | 0.0276 |
| B | 85 | 0.62 | ||||
| 3-HPMAe,j (μg/24 h) | A | 55 | 90 | 1.00 | 0.30 (0.19, 0.48) | < 0.0001 |
| B | 97 | 0.30 | ||||
| HMPMAe,k (μg/24 h) | A | 55 | 90 | 0.85 | 0.29 (0.19, 0.44) | < 0.0001 |
| B | 97 | 0.25 | ||||
| MHBMAe,l (μg/24 h) | A | 55 | 90 | 1.05 | 0.11 (0.05, 0.23) | < 0.0001 |
| B | 97 | 0.11 | ||||
| HEMAe,m (μg/24 h) | A | 55 | 90 | 0.83 | 0.52 (0.30, 0.88) | < 0.0001 |
| B | 97 | 0.43 | ||||
| 4-aminobiphenyl (ng/24 h)e | A | 55 | 90 | 0.86 | 0.29 (0.19, 0.42) | < 0.0001 |
| B | 97 | 0.25 | ||||
| 2-aminonaphthalene (ng/24 h)e | A | 55 | 90 | 0.88 | 0.15 (0.09, 0.25) | < 0.0001 |
| B | 97 | 0.13 | ||||
| o-Toluidine (ng/24 h)e | A | 55 | 90 | 1.01 | 0.36 (0.24, 0.52) | < 0.0001 |
| B | 97 | 0.36 | ||||
| 1-hydroxypyrene (ng/24 h)e | A | 55 | 90 | 1.15 | 0.37 (0.24, 0.57) | < 0.0001 |
| B | 97 | 0.42 | ||||
| FeNOe,n (ppb) | A | 54 | 180 | 0.99 | 1.52 (1.20, 1.93) | < 0.0001 |
| B | 93 | 1.51 | ||||
| WBCe,o count (109/L) | A | 56 | 180 | 0.99 | 0.85 (0.76, 0.94) | < 0.0001 |
| B | 93 | 0.84 | ||||
| eCOp,q (ppm) | A | 62 | 120/150 | 15.06 | −13.37 (−16.20, −10.54) | < 0.0001 |
| B | 112 | 1.69 | ||||
| TNeqp.r (mg/24 h) | A | 55 | 90 | −1.67 | −3.11 (−8.74, 2.53) | 0.0550 |
| B | 97 | −4.77 | ||||
| TNeqp,r (mg/24 h) | A | 53 | 180 | −4.70 | −1.13 (−5.21, 2.95) | 0.4529 |
| B | 85 | −5.84 | ||||
| S-PMAp,s (μg/24 h) | A | 55 | 90 | −0.74 | −2.84 (−4.51, −1.18) | < 0.0001 |
| B | 97 | −3.58 | ||||
| CEMAp,t (μg/24 h) | A | 55 | 90 | −2 | −158 (−212, −103) | < 0.0001 |
| B | 97 | −159 | ||||
| 11-dTx B2p,u (ng/24 h) | A | 53 | 180 | −100 | −173 (−399, 53) | 0.0396 |
| B | 85 | −274 | ||||
| 8-Epi-PGF2αp,v (ng/24 h) | A | 53 | 180 | −41 | −76 (−144, −7) | 0.0032 |
| B | 85 | −116 |
All analyses, except for eCO, were performed using biomarker levels at baseline (day 1) and on either day 90 or day 180, as indicated. eCO was analysed as the difference between the means of absolute values on days 120 and 150
aGroup A, continue to smoke combustible cigarettes, Group B, switch to THP
bN, number of participants (for details of participant composition refer to Supplementary Table 1)
cLS least squares
dGLS geometric least squares
eGLS mean and ratio shown for data log-transformed prior to calculation of change from baseline
fCI confidence interval: 99.94% CI shown for day 90; 99.245% CI shown for day 180
gSignificance threshold 0.0006 on day 90 and 0.00755 on day 180
hNNAL 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol
iNNN N-nitrosonornicotine
j3-HPMA 3-hydroxypropylmercapturic acid
kHMPMA 3-hydroxy-1-methylpropylmercapturic acid
lMHBMA monohydroxybutenyl-mercapturic acid
mHEMA 2-hydroxyethylmercapturic acid
nFeNO fractional exhaled nitric oxide
oWBC white blood cell
pLS mean and difference shown for untransformed data
qeCO exhaled carbon monoxide
rTNeq total nicotine equivalents (nicotine, cotinine, 3-hydroxycotinine and their glucuronide conjugates)
sS-PMA S-phenylmercapturic acid
tCEMA 2-cyanoethylmercapturic acid
u11-dTx B2 11-dehydrothromboxane B2
v8-Epi-PGF2α 8-epi-prostaglandin F2α type III