Table 1.

Trial schedule of assessments and interventions.

Schedule items		Time of assessments and interventions
		Baselinea	Day 1	1 month (wks 3-5)	3 months (wks 11-15)	6 months (wks 24-28)	9 months (wks 37-41)	12 months (wks 50-54)
Enrollment
	Eligibility screen	X
	Informed consent	X
Assessments
	Blood pressure	X		X	X	X	X	X
	Capillary glucose	X		X	X	X	X	X
	Physical assessment of height and weight	X
	Venous sample (5 mL) cytomegalovirus IgGb	X
	Venous sample (4 mL) CD8 TEMRAc immunosenescence (primary outcome)d	X				X		X
	Venous sample (36 mL) CD8 and CD4 immunosenescence (secondary outcomes), telomere length, and telomerase activity	X				X		X
	Venous sample (4 mL) oxidative stress, future use	X				X		X
	Venous sample (5 mL) future research use—optional consent	X				X		X
	Venous sample (5mL) hsCRPe and NT-proBNPf	X				X		X
	Endothelial function (EndoPAT [Peripheral Arterial Tone])	X				X		X
	Echocardiography	X						X
Interventions
	Randomization—stratified	X
	Dispensing of investigational medicinal product (IMP)		X	X	X	X	X	X
	Return of unused IMP and drug adherence			X	X	X	X	X
	Adverse events evaluation			X	X	X	X	X

^aBaseline assessments are completed after written consent is obtained and are performed before randomization.

^bIgG: immunoglobulin G.

^cTEMRA: T effector memory cells re-expressing CD45RA (CD45 expressing exon A).

^dResults from baseline immunosenescence sample are required for randomization.

^ehsCRP: high‐sensitivity C‐reactive protein.

^fNT-proBNP: N-terminal fragment of the prohormone brain-type natriuretic peptide.