Table 1.

Schedule of data collection

	Before observation period	Start of administration	Dosing period
	Within 4 weeks	Day 0	2 weeks	4 weeks	8 weeks	12 weeks	24 weeks
Allowance			Within ±1 week	Within ±1 week	Within ±2 weeks	Within ±2 weeks	Within ±4 weeks
Visit	1	2	3	4	5	6	7
Informed consent	X
Patient characteristics	X
Study drug administration		X
Symptom check		X
Adverse events check		X
Visceral fat area measured via CT		X					X
Body weight	X	X	X	X	X	X	X
Heart rate, blood pressure		X	X	X	X	X	X
Blood tests		X		X	X	X	X
Blood chemistry		X		X	X	X	X
Urine tests		X	X	X	X	X	X
Insulin, bone marker, inflammation marker		X				X	X
α1-Microglobulin		X					X
Adipocytokine		X					X
Waist circumference	X	X	X	X	X	X	X
Hand griping test		X				X	X
Medication adherence check			X	X	X	X	X
Special examination*		X					X
Screening blood examination	X

*Special examination includes whole-body DXA, dietary behaviour questionnaire, respiratory quotient, basal metabolism, and calorie and glucose intake for patients.

DXA, dual-energy X-ray absorption.