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. 2021 Dec 27;22:962. doi: 10.1186/s13063-021-05915-0

Table 1.

Schedule of evaluations

Visit Screening
−10 to −6 weeks
Run-ina
−6 to 0 weeks
Randomisation
0 weeks
Follow-upb
3 monthly 6 monthly Annually Finalc
Time window for evaluation N/A + 2 days N/A ±14 days ±14 days ±14 days N/Ac
Informed consent (prior to or at screening) X
Assessment of eligibility X
Demographics X
Anthropometrics—height and weight X Xf Xf
Behavioural—smoking X
Medical history X
Concomitant medications X X X
AAA imaging (standard care)h X X X
Blood tests—creatinine, eGFR, HbA1c, CRP (if available), LDL-C (if available)d X Xg Xg
Blood sample for biomarker sub-studye X Xe X
QoL questionnaires: SF-36, AneurysmDQoL X X X
Run-in medication dispensed X
Randomisation X
Study medication dispensed X X X
Study medication adherence X X X X X
AESI reporting X X X X X
Serious adverse event reporting X X X X X
Assessment of exploratory outcomes not classified as SAEs (diagnosis of cancer, diagnosis of diabetes, symptomatic gout) X X X X
Health economic assessment questions X X

aParticipants will be contacted by telephone fortnightly during the 6-week run-in period

bParticipants will be contacted every 3 months after randomisation

cParticipants will undergo a final follow-up within 3 months of the date of the last adjudicated primary outcome event

dIf blood tests are available from within 6 months prior to screening, no need to repeat tests at screening

eOnly for participants who have consented to the biomarker sub-study. Samples will be collected at entry, at years 1 and 3, and at the final scheduled follow-up

fWeight only

geGFR only. If blood tests are available from within 3 months prior to annual follow-up/final follow-up, no need to repeat tests

hIf imaging is available within 12 months of screening/annual follow-up, no need to repeat tests