Table 1.
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 |
if appropriate (i.e. only if participants were still using the same products of the study).