Skip to main content
. 2020 Jan 8;17:100518. doi: 10.1016/j.conctc.2020.100518

Table 1.

Study schedule.


Visit 0 (screening)
V0
Visit 1 (baseline)
V1
Visit 2
V2
Visit 3
V3
Visit 4
V4
Visit 5
V5
Visit 6
V6
Visit 7 Follow-up
V7
Assessments ≤7 days after V0 1 week after V1 ± 3 days 2 weeks after V1
±3 days
4 weeks after V1
±3 days
8 weeks after V1
±7 days
12 weeks after V1
±7 days
24 weeks after V1
±7 days
Medical Hx X
Tobacco/vaping products Hx X
Eligibility criteria checks X
Step Test Training (10–15 min) X
Instructions for urine collection and storage; provision of containers X X
Patient Information Sheet X
Informed consent X
Randomization X
Device Familiarization (30–60 min) X
Dispense Device (plus 1 wk supply of tobacco sticks for iQOS or liquid for JustFog) X
Dispense 1 wk supply of tobacco sticks for iQOS or liquid for JustFog X
Dispense 2 wk supply of tobacco sticks for iQOS or liquid for JustFog X
Dispense 4 wk supply of tobacco sticks for iQOS or liquid for JustFog X X
Cigarette/day X X X X X X X X
eCO X X X X X X X X
Vital Signs (BP, HR) X X X X X X X
Weight and height X X X
Urine sample processing X X
Product use recording X X X X X X
Product use checks (collect used and unused tobacco sticks and liquid refill containers) X X X X X Xa
mCEQ X X X Xa
Smoking Cue Appeal X X X X Xa
ITUQ X X X Xa
Risk perception questionnaires (PRI-P CC; PRI-P RRP) X X X X Xa
EQ-VAS X X X X
Step test X X X X
Safety reporting/AEs X X X X X X Xa
Product failure reporting X X X X X Xa
a

if appropriate (i.e. only if participants were still using the same products of the study).