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. 2024 Nov 24;14(11):e088862. doi: 10.1136/bmjopen-2024-088862

Table 2. Patient inclusion and exclusion criteria.

Inclusion criteria Exclusion criteria
1 Men and women aged at least 20 years and under 80 years at the time of obtaining consent Patients taking contraindications.Ciclosporin, rifampicin, steroids (excluding topical and inhaled drugs), amiodarone and breast cancer drugs.
2 Patients with fatty liver diagnosed histologically within 1 year prior to obtaining consent or imaging examination within 6 months prior to obtaining consent and who have failed exercise and diet therapy for at least 3 months. Patients with body mass index <18.5 kg/m2 at the time of obtaining consent.
3 Patients with hypertriglyceridaemia (150–500 mg/dL) within 91 days prior to obtaining consent. Patients who have been diagnosed with liver cirrhosis at the time of obtaining consent
4 Patients with elevated alanine aminotransferase (43–100 IU/L for men, 24–100 IU/L for women) within 91 days prior to obtaining consent. Patients with findings of portal hypertension (varicose veins, ascites, encephalopathy and splenomegaly) at the time of obtaining consent.
5 Patients whose daily alcohol consumption (ethanol equivalent) is less than 30 g/day for men and less than 20 g/day for women at the time of obtaining consent Patients with total bilirubin >2× the upper limit of normal within 91 days prior to obtaining consent, excluding Girbert syndrome.
6 Patients with hepatitis C, hepatitis B (excluding inactive carriers), autoimmune hepatitis, primary biliary cholangitis or other hepatic complications that have been ruled out at the time of obtaining consent. Platelet count 80×109/L within 91 days prior to obtaining consent.
7 Patients whose written consent to participate in this study has been obtained. Serum creatinine level of 1.5 mg/dL or higher within 91 days prior to obtaining consent.
8 Patients with gallstones or biliary obstruction at the time of obtaining consent.
9 Patients with severe infection, preoperative or postoperative or severe trauma at the time of obtaining consent.
10 Patients who have used fibrates within 91 days prior to obtaining consent.
11 Patients with 10% weight change in 91 days prior to obtaining consent.
12 Patients who have undergone bariatric surgery or are scheduled for surgery during the study period.
13 Patients with a history of type I diabetes mellitus.
14 Patients with HbA1c >9.5% within 91 days prior to obtaining consent(If HbA1c >9.5%, re-entry will be possible after improvement by treatment.).
15 Patients with psychosis, alcoholism, drug addiction or narcotic addiction that would affect compliance with the research protocol.
16 Patients who participated in other clinical trials in 100 days prior to obtaining consent.
17 Pregnant women or patients who may be pregnant.
18 Patients with complications of malignant tumoursHowever, patients who have undergone radical surgery or completed anticancer drug administration may enrol. Patients under observation and evaluation for malignant tumours are excluded.
19 Other patients who are judged by the principal investigator to be inappropriate as participants of this study.

HbA1c, haemoglobin A1c