Table 1.
(A) A schedule of the study visits. (B) Assessments performed prior to randomisation (visit 1) and at each following visit (visit 2 to visit 5)
| (A) A schedule of the study visits | |
| Visit 0 (screening visit) | Within 28 days prior to visit 1 |
| Visit 1 | Day 1 |
| Visit 2 | Day 90 (±5 days) |
| Visit 3 | Day 180 (±7 days) |
| Visit 4 | Day 360 (±7 days) |
| Visit 5 | Day 720 (±7 days) |
| (B) Assessments performed prior to randomisation (visit 1) and at each following visit (visit 2 to visit 5) |
| Review of inclusion/exclusion criteria* |
| Completion of case report form* |
| Review of concomitant medication |
| Number of cigarettes consumed on a daily basis |
| Pregnancy test (for female participants) or review of pregnancy status |
| Vital signs (blood pressure and heart rate) |
| Waist circumference, height and weight, body composition (fat and skeletal muscle) |
| Fasting blood sample for: |
| Complete blood count including white cell count, haemoglobin, platelets |
| Lipid profile (triglycerides, high-density lipoprotein and low-density lipoprotein) |
| Fasting glucose level, glycated haemoglobin |
| Insulin level for HOMA (Homeostatic Model Assessment for Insulin Resistance) index |
| Plasma creatinine levels |
| Testosterone levels (men only) |
| Urine albumin to creatinine ratio |
| Spirometry |
| Carbon monoxide breath test |
| Fagerström questionnaire for Nicotine/Cigarette Dependence |
| Diabetes Quality of Life questionnaire |
*Performed prior to randomisation (visit 1) only.