Table 2.
Visit schedule
| Study time points (months) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | 0 | ½ | 3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 | |
| Assessment | Visit 1 | Visit 2 | Phone Call | Visit 3 | Visit 4 | Phone Call | Visit 5 | Phone Call | Visit 6 | Phone Call | Visit 7 |
| Consent | x | ||||||||||
| Enrolment/randomisation | x | ||||||||||
| CT angiography | x | xa | x | ||||||||
| Ultrasound | x | x | x | x | x | ||||||
| Blood test (safety) | x | x | x | x | |||||||
| Blood collection (study) | x | x | x | x | x | ||||||
| Resting brachial BP | x | x | x | x | x | x | |||||
| SF-36 questionnaire | x | x | x | ||||||||
| Physical assessments | x± | x | x | x | x | x | |||||
| Medical examination | x | x | x | x | |||||||
| Resting ABI | x | x | x | ||||||||
| Collection of study medication | x | x | x | x | |||||||
| Return of study medication | x | x | x | x | |||||||
| Event outcomes | x | x | x | x | x | ||||||
| AE and compliance check | x | x | x | x | x | x | x | x | x | ||
Physical assessments include: resting BP, resting heart rate, weight, hip and waist measurements, ±indicates an additional assessment of height. ABI, ankle brachial-index; AE, adverse effects; BP, blood pressure; CT, computed tomography
aThe Leiden and Stanford study centres will not perform 12-month CTAs due to local ethics regulations. The Stanford centre will utilize a slightly different study schedule. In place of the 2-week phone call and 3-month visit, participants will attend for a safety visit at 1 month for assessment of adherence to study treatment and medication side effects. Study medications will be prescribed at 3-month intervals with AE and compliance checks at 3, 9, 15 and 21 months