| 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 | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Enrolment/randomisation | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | Â |
CT angiography | x | Â | Â | Â | Â | Â | xa | Â | Â | Â | x |
Ultrasound | x | Â | Â | Â | x | Â | x | Â | x | Â | x |
Blood test (safety) | x | Â | Â | x | Â | Â | x | Â | Â | Â | x |
Blood collection (study) | x | Â | Â | Â | x | Â | x | Â | x | Â | x |
Resting brachial BP | x | Â | Â | x | x | Â | x | Â | x | Â | x |
SF-36 questionnaire | x | Â | Â | Â | Â | Â | x | Â | Â | Â | x |
Physical assessments | x± |  |  | x | x |  | x |  | x |  | x |
Medical examination | x | Â | Â | x | Â | Â | x | Â | Â | Â | x |
Resting ABI | x | Â | Â | Â | Â | Â | x | Â | Â | Â | x |
Collection of study medication | Â | x | Â | Â | x | Â | x | Â | x | Â | Â |
Return of study medication | Â | Â | Â | Â | x | Â | x | Â | x | Â | x |
Event outcomes | Â | Â | Â | x | x | Â | x | Â | x | Â | x |
AE and compliance check | Â | Â | x | x | x | x | x | x | x | x | x |