Table 1 Study schedule
Procedure | BL Visit | Wk4 | Wk8 | Wk12 | Wk24 | Wk52 | Early termination visit | |
|---|---|---|---|---|---|---|---|---|
Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | |||
Informed consent | X | |||||||
Inclusion/exclusion criteria (review) | X | |||||||
CRF | Sociodemografic factors | X | ||||||
Smoking Hx | X | |||||||
no. cig/day | X | X | X | X | X | X | X | |
Physical examination | X | X | ||||||
FTDC, GN-SBQ, QLS, BACS | X | X | X | X | X | |||
eCO | X | X | X | X | X | X | X | |
HR, BP | X | X | X | X | X | X | X | |
Weight | X | X | X | |||||
AEs | X | X | X | X | X | X | X | |
Randomization into either study group A (Ecig 24 mg), B (Ecig o mg), or C (paipo) | X | |||||||
Dispense 4-weeks supply of either nicotine or no-nicotine or paipo (depending on arm allocation) | X | X | X | X (x3) | ||||
Dispense 4-weeks’ study diary for AEs | X | X | X | X (x3) | ||||
Spirometry | X | X | X | X | X | |||
Book for next appointment in 4 weeks (week-4; study visit 2) | X | X | X | X (x3) | X(x6) | |||
Craving/VAS | X | X | X | X | X | X | X | |
MNWS | X | X | X | X | X | X | X | |
PANSS | X | X | X | X | X | X | ||