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. 2024 May 21;31(11):1620–1633. doi: 10.5551/jat.64896

Supplementary Table 2. Eligibility criteria.

Inclusion criteria Patients who met all of the following criteria were included in this study:

1. Patients with fasting TG levels ≥ 150 mg/dL and <500 mg/dL within 12 weeks prior to the provision of their

consent

2. Patients diagnosed with steatosis by abdominal ultrasound within 6 months prior to the provision of their consent

3. Male patients with ALT levels >40 IU/L or female patients with ALT levels >30 IU/L within 12 weeks prior to the

provision of their consent

4. Male and female patients aged ≥ 20 years
5. Patients who provided written informed consent
Exclusion criteria Patients who met any of the following criteria were excluded from this study:
1. Patients with ALT levels ≥ 250 IU/L
2. Patients who were deemed to be excessive drinkers (ethanol intake of ≥ 210 g/week for male patients or ≥ 140 g/week for female patients)
3. Patients who used fibrates within 12 weeks prior to the provision of their consent
4. Patients who used omega-3 fatty acid agents or relevant supplements within 6 months prior to the provision of their consent
5. Patients who used drugs prohibited in this study (e.g., pioglitazone, vitamin E, SGLT2 inhibitors, GLP-1 receptor antagonists, study agent, control agent, or any drug/supplement with the same indications) within 12 weeks prior to the provision of their consent
6. Patients with BMI of <22 kg/m2
7. Patients showing unstable glycemic control (HbA1c of 8% or higher within 12 weeks prior to the provision of their consent)
8. Patients with cirrhosis
9. Patients with plasma creatinine levels ≥ 1.5 mg/dL
10. Patients with cholelithiasis or biliary obstruction
11. Patients who had chronic liver diseases with any of the following steatosis except for NAFLD:
(i) Viral hepatitis (hepatitis B, hepatitis C)
(ii) Autoimmune hepatitis
(iii) Primary biliary cholangitis
(iv) Primary sclerosing cholangitis
(v) Drug-induced liver injury
(vi) Endocrine/metabolic hepatitis (hyperthyroidism, Wilson disease, hemochromatosis, or alpha-1 antitrypsin deficiency)
12. Patients who had a malignant tumor or who were expected to experience recurrence of a malignant tumor after amelioration
13. Patients who underwent blood collection or blood donation of ≥ 200 mL within 12 weeks prior to the provision of their consent
14. Patients with a history of severe drug hypersensitivity (e.g., anaphylactic shock)
15. Patients who were breastfeeding, pregnant, possibly pregnant, or planning to be pregnant
16. Patients who were participating in other interventional trials
17. Patients who had a history of hypersensitivity to or had contraindications to the study agent or control agent in this study
18. Patients who required a legal representative for the provision of consent
19. Patients who were considered to be unsuitable for study participation by the investigators

TG, triglyceride; ALT, alanine aminotransferase; SGLT2, sodium-glucose cotransporter 2; GLP-1, glucagon-

like peptide 1; BMI, body mass index; NAFLD, non-alcoholic fatty liver disease.