Biovalidation
CPD, ’s breath
Biovalidation was sought at 52 weeks in individuals who reported 7-day (or greater) PPA on the associated questionnaire. A video call with study staff and the participant was scheduled within 7 days following the participant’s response to the associated questionnaire. At the beginning of the biovalidation visit, participants were asked their CPD, 7-day PPA status, and whether they had smoked any other noncigarette (eg, pipes, cigars, or hookah) or combustible materials (eg, cloves or marijuana) over the previous 24 hours.Participants who indicated that they were not at least 7 days abstinent or that they had smoked ≥1 CPD were not eligible to undergo further biovalidation testing during the visit. Participants who indicated that they were at least 7 days abstinent and had not smoked cigarettes were eligible to proceed with the testing. Participants who indicated that they had smoked any other combustible materials over the previous 24 hours were eligible to undergo a biovalidation test at that same visit, with the possibility of scheduling a follow-up biovalidation test for the following day with instructions not to smoke the previously reported other combustible substance or substances over the intervening 24-hour period. If a participant was eligible for biovalidation and biovalidation was not achieved, the reason was noted (eg, did not schedule or attend a biovalidation study visit, reported change in smoking status at the outset of visit, or the participant’s breath CO sample was ≥10 ppm).Biovalidation was obtained through CO breath sampling. Participants in the intervention arm used their Pivot Breath Sensor for this test. Shortly before the visit, participants in the control arm were mailed a Pivot Breath Sensor that was limited to 10 breath samples. During the video call, participants held the breath sensor up to the screen immediately after completing the breath sample so that the study staff could see and record the CO ppm measurement on the sensor screen. A CO value of <10 ppm was considered consistent with abstinence [