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. Author manuscript; available in PMC: 2022 Aug 1.
Published in final edited form as: Lancet Respir Med. 2021 Apr 12;9(8):840–850. doi: 10.1016/S2213-2600(21)00022-9

Table:

Baseline characteristics

Cigarette substitute group (n=130) ENDS with 0 mg/mL nicotine group (n=130) ENDS with 8 mg/mL nicotine group (n=130) ENDS with 36 mg/mL nicotine group (n=130) Overall (n=520)

Age, years 46·1 (12·4) 45·7 (11·4) 45·6 (11·7) 47·4 (11·1) 46·2 (11·6)
Sex
 Female 79 (61%) 80 (62%) 80 (62%) 67 (52%) 306 (59%)
 Male 51 (39%) 50 (38%) 50 (38%) 63 (48%) 214 (41%)
Ethnicity
 White non-Hispanic 83 (64%) 92 (71%) 87 (67%) 88 (68%) 350 (67%)
 Black non-Hispanic 39 (30%) 33 (25%) 37 (28%) 36 (28%) 145 (28%)
 Other 8 (6%) 5 (4%) 6 (5%) 6 (5%) 25 (5%)
Some college education or higher 76 (58%) 72 (55%) 83 (64%) 79 (61%) 310 (60%)
Income >US$39 999* 51 (40%) 47 (37%) 51 (41%) 60 (46%) 209 (41%)
Cigarettes smoked per day, mean over 7 days 18·37 (7·13) 18·79 (8·35) 19·45 (8·73) 17·76 (6·52) 18·59 (7·74)
Exhaled CO, ppm 23·65 (12·54) 23·35 (12·23) 21·84 (9·80) 21·94 (10·48) 22·69 (11·32)
Penn State Cigarette Dependence Index score 13·4 (3·0) 13·7 (2·7) 13·2 (3·0) 13·2 (3·2) 13·4 (3·0)
Menthol cigarette smoking 87 (67%) 88 (68%) 81 (62%) 77 (59%) 333 (64%)
Use of other tobacco products in past 30 days 4 (3%) 9 (7%) 10 (8%) 8 (6%) 31 (6%)
Urinary total NNAL, pg/mg creatinine
 Median (IQR) 441·42 (683·19) 499·76 (612·20) 419·97 (835·64) 544·38 (825·33) 473·18 (710·61)
 Geometric mean (95% CI) 404·22 (33047–49444) 440·69 (366·42–530·01) 425·04 (347·34–520·11) 432·73 (339·33–551·83) 425·45 (383·64–471·81)
Urinary cotinine, ng/mg creatinine
 Median (IQR) 1641·21 (2018·30) 1593·17 (1564·13) 1733·97 (2057·46) 1871·47 (2137·68) 1662·45 (1908·58)
 Geometric mean (95% CI) 1441·56 (1227·93–1692·35) 1444·53 (1241·45–1680·83) 1729·53 (1493·97–2002·23) 1658·74 (1411·23–1949·67) 1563·39 (1447·38–1688·70)

Data are mean (SD) or n (%) unless otherwise stated. Demographic characteristics and use of other tobacco products were assessed by self-report at the in-person screening visit (1 week before randomisation). Cigarettes smoked per day, exhaled CO, Penn State Cigarette Dependence Index score, menthol cigarette smoking status, urinary total NNAL, and urinary cotinine were assessed at the baseline visit (at randomisation). There were no significant differences in baseline characteristics between groups (p>0·05 for each characteristic). ENDS=electronic nicotine delivery system. ppm=parts per million. NNAL=4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol.

*

Two participants in the cigarette substitute group, three in the 0 mg/mL group, and five in the 8 mg/mL group had missing income data.

Calculated using self-reported timeline follow-back for the 7 days before the randomisation visit (collected in-person at randomisation).