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. 2023 Aug 21;13(8):e075673. doi: 10.1136/bmjopen-2023-075673

Table 2.

Data collection

Day 0 Week 4 Week 24 Week 48
Informed consent x
Randomisation x
Demographics* x
Framingham Risk Score x x x
SF-12† x x x
Body weight x x x
Vital signs x x x
Blood tests‡ x x x
HIV safety blood tests§ x x x x
Transient elastography/Controlled Attenuated Parameter x x x
CT¶ (x) (x) (x)
DEXA** x x x
cIMT†† x x x
MRI substudy
Cardiac MRI‡‡ x x
24 hours ECG Holter monitoring x x

*Age, gender, tobacco use, alcohol consumption, medication, medical history, nursing home residency and activities of daily living.

†12-Item Short-Form Health Survey (SF-12).

‡HIV safety blood tests: Plasma HIV-RNA and CD4 count.

§Blood tests: leucocytes, platelets, haemoglobin, creatinine, urea, sodium, potassium, bilirubin, alanine aminotransferase, lactate dehydrogenase, erythrocyte fraction. Metabolism: Fasting p-glucose, insulin, glycated haemoglobin, total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, triglyceride. Inflammation: High-sensitive C reactive protein, interleukin 1 and 6. Coagulation: D-dimer, factor 2, 7 and 10, fibrinogen. Platelet function: soluble P-selectin, soluble glycoprotein VI. Endothelial function: Vascular cell adhesion molecule 1, intercellular adhesion molecule 1, cardiac: N-terminal pro-B-type natriuretic peptide, troponin T.

¶Low dose CT of thorax and abdomen to determine coronary artery calcium score, visceral adipose tissue, subcutaneous adipose tissue and liver steatosis.

**Dual energy X-ray absorptiometry (DEXA), optional.

††Carotid intima-media thickness (cIMT) determined by ultrasound.

‡‡Cardiac MRI substudy (optional).

§§Blood pressure, heart rate