Efficacy and Safety of Single-Pill Combination of Rosuvastatin and Ezetimibe in Chinese Patients with Primary Hypercholesterolemia Inadequately Controlled by Statin Treatment (ROZEL): A Randomized, Double-Blind, Double Dummy, Active-Controlled Phase 3 Clinical Trial

Figures

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  Fig. 1. Study flowchart. Completion of study, completion of follow-up period regardless of continuing the IMP; E10 ezetimibe 10 mg, IMP investigational medicinal product, R10 rosuvastatin 10 mg, SPC single-pill combination, LDL-C low-density lipoprotein cholesterol; exclusion criterion #10, any patient deemed unfit for participation by the investigators

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  Fig. 2. Least square (LS) mean (SE) of percent changes in low-density lipoprotein cholesterol (LDL-C) from baseline to week 4 and week 8. LDL-C low-density lipoprotein cholesterol, LS Mean least square mean, LSMD least square mean differences, SE standard error, R10 rosuvastatin 10 mg, E10 ezetimibe 10 mg. The P value is followed by a * if statistically significant according to the fixed hierarchical approach used to ensure a strong control of the overall type-I error rate at the 0.05 level

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  Fig. 3. Percent changes in low-density lipoprotein cholesterol (LDL-C) from baseline to week 8: subgroup analysis. LDL-C low-density lipoprotein cholesterol, LS Mean least square mean, SE standard error, CI confidence interval, R10 rosuvastatin 10 mg, E10 ezetimibe 10 mg, BMI body mass index

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  Fig. 4. The proportion of participants attaining target LDL-C < 2.6 mmol/l at week 8. LDL-C low-density lipoprotein cholesterol, OR odds ratio, CI confidence interval, R10 rosuvastatin 10 mg, E10 ezetimibe 10 mg. The P value is followed by a * if statistically significant according to the fixed hierarchical approach used to ensure a strong control of the overall type-I error rate at the 0.05 level

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  Fig. 5. The percent changes of TC (a) TG (b) and HDL-C (c) from baseline to week 4 and week 8. LS Mean least square mean, LSMD least square mean differences, SE standard error, R10 rosuvastatin 10 mg, E10 ezetimibe 10 mg, TC total cholesterol, AMD adjusted mean difference, TG triglyceride, HDL-C high-density lipoprotein cholesterol. The P value is followed by a * if statistically significant according to the fixed hierarchical approach used to ensure a strong control of the overall type-I error rate at the 0.05 level