Efficacy and safety of levothyroxine monotherapy in lowering the risk of cardiovascular disease in older adults with subclinical hypothyroidism: research protocols of a multicenter, open-label, randomized controlled trial

Table 1 Schedule of assessments

Steps	Projects	Screening randomization		Follow-up
	No. of visit	0	1	2	3	4	5	6
	Weeks	− 12 to − 4	0	4	8	12	24	48
1	Informed consent	×
2	Inclusion/exclusion criteria	×
3 Clinical data	Basic data		×
	Randomization		×
	Concomitant medication		×
	Concomitant illness		×
4 Examination	TSH		×	×	×	×	×	×
	Vascular ultrasound		×				×	×
	BMD		×					×
	Blood lipids (TC, LDL-C)		×					×
5	Adverse events	×	×	×	×	×	×	×
6	Deviation from the protocol	×	×	×	×	×	×	×

TSH, thyroid-stimulating hormone; BMD, bone mineral density; TC, total cholesterol; LDL-C, low-density lipoprotein cholesterol

ISSN: 1745-6215