Observation items | Registration | Treatment period | Discontinuation | ||
0 week | 8 weeks | 16 weeks | |||
(Visit 1) | (Visit 2) | (Visit 3) | |||
Informed consent | ○ | ||||
Eligibility | ○ | ||||
Patient characteristics | ○ | ○ | |||
Drug adherence | ○ | ○ | ○ | ○ | |
ApoB-48 | ○ | ○ | ○ | ||
Remnant lipoprotein cholesterol | ○ | ○ | ○ | ||
Small dense LDL | ○ | ○ | ○ | ||
Lipids | ○ | ○ | ○ | ||
Lipoprotein subfractions | ○ | ○ | ○ | ||
Apolipoprotein | ○ | ○ | ○ | ||
Biochemical parameters | ○ | ○ | ○ | ○ | |
Plasma glucose | ○ | ○ | ○ | ○ | |
IRI and glycated haemoglobin A1c | ○ | ○ | ○ | ||
Fibrinogen | ● | ● | ● | ● | |
Height | ○ | ||||
Physical examinations | ○ | ○ | ○ | ○ | |
Other examinations | ● | ● | ● | ||
Adverse events and diseases | ○ | ○ | ○ | ○ |
Physical examinations include blood pressure, body weight, body mass index (BMI) and waist circumference.
Other examinations include lean mass, fat mass, muscle mass, liver to spleen ratio and visceral fat area.
White circles, required items.
Solid circles, optional items.
ApoB-48, apolipoprotein B-48; IRI, immunoreactive insulin; LDL, low-density lipoprotein.