| Online | Call 1 | Call 2 | Call 3 | Call 4–5 | ||
---|---|---|---|---|---|---|---|
Timing Description | Week 0 Screening, Baseline and Randomisation | Quit date (QD) Endpoint | One month after QD Endpoint | Three months after QD Endpoint | Six and 12Â months after QD Endpoint | ||
Case Record Form (CRF) | CRF-A | CRF-B | CRF-R | C-QD | C-1 | C-3 | C-6, C-12 |
General data | |||||||
 Eligibility criteria | X |  |  |  |  |  |  |
 Consent | X | X |  |  |  |  |  |
 Age, gender, ethnicity, education |  | X |  |  |  |  |  |
 Height |  | X |  |  |  |  |  |
 Weight |  | X |  |  |  | X | X |
 Current medicationd |  | X |  | X | X | X | X |
 Health state |  | X |  |  |  | X | X |
 Alcohol and cannabis use |  | X |  |  |  |  |  |
 Pregnancy | X |  |  | X | X | X | X |
Smoking information | |||||||
 Type of tobacco smoked |  | X |  |  |  |  |  |
 Cigarettes smoked per dayb |  | X |  | X | X | X | X |
 Age started |  | X |  |  |  |  |  |
 Years smoked |  | X |  |  |  |  |  |
 Time to first cigarette upon waking |  | X |  |  |  |  |  |
 Household smoking |  | X |  |  |  |  |  |
 Around others that use e-cigarettes |  | X |  |  |  |  |  |
 Previous quit attempts and method |  | X |  |  |  |  |  |
 Motivation to quit |  | X |  |  |  |  |  |
 Nicotine withdrawal and urge to smoke |  | X |  |  |  | X |  |
 Any smoking in last seven days |  |  |  |  | X | X | X |
 Any smoking since Quit date |  |  |  |  | X | X | X |
 Lapse and relapse back to smoking |  |  |  |  | X | X | X |
 Biochemical verification in quitterse |  |  |  |  |  |  | X |
Follow-up details | |||||||
 Quit date verified |  |  |  | X |  |  |  |
 Contact detailsf |  |  | X | X | X | X | X |
 Treatment allocation |  |  | X |  |  |  |  |
 Date products delivered |  |  | X |  |  |  |  |
Use of other cessation methods | |||||||
 Type of cessation method used |  |  |  |  | X | X | X |
Other outcomes | |||||||
 Acceptability |  |  |  |  |  | X |  |
 Medication use and compliance |  |  |  | X | X | X |  |
 Crossover |  |  |  | X | X | X | X |
 Health-related quality of life |  | X |  |  |  | X | X |
 Changes to e-cigarettea |  |  |  | X | X | X | X |
 Dual use |  |  |  |  | X | X | X |
 Continuation of allocated treatment |  |  |  |  |  |  | X |
 Adverse eventsc |  |  |  | X | X | X | X |
 Serious adverse eventsc |  |  |  | X | X | X | X |
 Cost information |  |  |  |  |  |  | X |