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Table 1 Entry and exclusion criteria

From: RESEARCH (Recognized effect of Statin and ezetimibe therapy for achieving LDL-C Goal), a randomized, doctor-oriented, multicenter trial to compare the effects of higher-dose statin versus ezetimibe-plus-statin on the serum LDL-C concentration of Japanese type-2 diabetes patients design and rationale

Entry criteria
 Japanesess
 Type 2 diabetes mellitus
 Age ≥ 20 years
 Using atorvastatin 10 mg/day or pitavastatin 1 mg/day for > 1 month
 LDL-C ≥ 120 mg/dL for patients without CAD , LDL-C ≥ 100 mg/dL for patients with CAD
Exclusion criteria
 Pregnant, possible to become pregnant, or brest-feeding to baby(s)
 Hypersensitive to the medicines concerned
 Liver dysfunction
 HbA1C ≥ 9.4%
 Serum creatinine ≥ 2.0 mg/dL
 Triglyceride ≥ 400 mg/dL
 Secondary dyslipidemia, drug-induced dyslipidemia
 Homozygotic familial hypercholesterolemia
 Other non-specific reason, such as poor adherence
  1. CAD: coronary artery disease.