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Height
Time frame: Baseline, Month 12, Month 24
Body height measured in centimeters using a height and weight measuring instrument. Reported as mean value at each assessment time point.
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Weight
Time frame: Baseline, Month 12, Month 24
Body weight measured in kilograms using a height and weight measuring instrument. Reported as mean value at each assessment time point.
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Systolic Blood Pressure
Time frame: Baseline, Month 12, Month 24
Systolic blood pressure measured in millimeters of mercury (mmHg) using an automated sphygmomanometer after 5 minutes of rest. Reported as mean value at each assessment time point.
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Diastolic Blood Pressure
Time frame: Baseline, Month 12, Month 24
Diastolic blood pressure measured in millimeters of mercury (mmHg) using an automated sphygmomanometer after 5 minutes of rest. Reported as mean value at each assessment time point.
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Heart Rate on 12-Lead Electrocardiogram
Time frame: Baseline, Month 12, Month 24
Heart rate measured in beats per minute (bpm) from 12-lead electrocardiogram recorded after 10 minutes of rest in supine position. Reported as mean value at each assessment time point.
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PR Interval on 12-Lead Electrocardiogram
Time frame: Baseline, Month 12, Month 24
PR interval measured in milliseconds (ms) from 12-lead electrocardiogram. Reported as mean value at each assessment time point.
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QRS Duration on 12-Lead Electrocardiogram
Time frame: Baseline, Month 12, Month 24
QRS duration measured in milliseconds (ms) from 12-lead electrocardiogram. Reported as mean value at each assessment time point.
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QTc Interval on 12-Lead Electrocardiogram
Time frame: Baseline, Month 12, Month 24
Corrected QT interval (QTc) measured in milliseconds (ms) using Bazett's formula from 12-lead electrocardiogram. Reported as mean value at each assessment time point.
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Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline, Month 12, Month 24
Left ventricular ejection fraction measured as percentage (%) using two-dimensional echocardiography with Simpson's biplane method. Higher values indicate better cardiac function. Reported as mean value at each assessment time point.
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Left Ventricular End-Diastolic Diameter (LVEDD)
Time frame: Baseline, Month 12, Month 24
Left ventricular end-diastolic diameter measured in millimeters (mm) using M-mode echocardiography. Reported as mean value at each assessment time point.
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Concentration of Lactate Dehydrogenase (LDH)
Time frame: Baseline, Month 12, Month 24
Serum lactate dehydrogenase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.
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Concentration of Alpha-Hydroxybutyrate Dehydrogenase (α-HBDH)
Time frame: Baseline, Month 12, Month 24
Serum alpha-hydroxybutyrate dehydrogenase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value at each assessment time point.
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Concentration of Creatine Kinase (CK)
Time frame: Baseline, Month 12, Month 24
Serum creatine kinase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.
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Concentration of Creatine Kinase-MB (CK-MB)
Time frame: Baseline, Month 12, Month 24
Serum creatine kinase-MB isoenzyme activity measured in units per liter (U/L) using immunoinhibition assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.
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Urine Occult Blood
Time frame: Baseline, Month 12, Month 24
Presence of occult blood in urine detected using dipstick method. Reported as number and percentage of participants with positive result (1+ or greater) at each assessment time point.
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Urine Protein
Time frame: Baseline, Month 12, Month 24
Presence of protein in urine detected using dipstick method. Reported as number and percentage of participants with positive result (1+ or greater) at each assessment time point.
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Concentration of Total Bilirubin
Time frame: Baseline, Month 12, Month 24
Serum total bilirubin concentration measured in micromoles per liter (μmol/L) using diazo method. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.
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Concentration of Total Protein
Time frame: Baseline, Month 12, Month 24
Serum total protein concentration measured in grams per liter (g/L) using biuret method. Reported as mean value at each assessment time point.
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Concentration of Albumin
Time frame: Baseline, Month 12, Month 24
Serum albumin concentration measured in grams per liter (g/L) using bromocresol green method. Reported as mean value and number of participants with values below lower limit of normal (LLN) at each assessment time point.
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Concentration of Direct Bilirubin
Time frame: Baseline, Month 12, Month 24
Serum direct (conjugated) bilirubin concentration measured in micromoles per liter (μmol/L) using diazo method with caffeine accelerator. Reported as mean value at each assessment time point.
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Activity of Aspartate Aminotransferase (AST)
Time frame: Baseline, Month 12, Month 24
Serum aspartate aminotransferase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.
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Activity of Alanine Aminotransferase (ALT)
Time frame: Baseline, Month 12, Month 24
Serum alanine aminotransferase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.
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Concentration of Globulin
Time frame: Baseline, Month 12, Month 24
Serum globulin concentration calculated as the difference between total protein and albumin concentrations, measured in grams per liter (g/L). Reported as mean value at each assessment time point.
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Concentration of Uric Acid
Time frame: Baseline, Month 12, Month 24
Serum uric acid concentration measured in micromoles per liter (μmol/L) using uricase method. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.
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Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline, Month 12, Month 24
Estimated glomerular filtration rate calculated in milliliters per minute per 1.73 square meters (mL/min/1.73m²) using CKD-EPI equation based on serum creatinine and cystatin C. Higher values indicate better kidney function. Reported as mean value and number of participants with eGFR <60 mL/min/1.73m² at each assessment time point.
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Concentration of Total Cholesterol
Time frame: Baseline, Month 12, Month 24
Serum total cholesterol concentration measured in millimoles per liter (mmol/L) using enzymatic colorimetric assay after overnight fasting. Reported as mean value at each assessment time point.
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Concentration of Triglycerides
Time frame: Baseline, Month 12, Month 24
Serum triglyceride concentration measured in millimoles per liter (mmol/L) using enzymatic glycerol phosphate oxidase method after overnight fasting. Reported as mean value at each assessment time point.
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Concentration of Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline, Month 12, Month 24
Serum LDL-C concentration measured in millimoles per liter (mmol/L) using direct enzymatic assay or calculated using Friedewald formula after overnight fasting. Lower values indicate better cardiovascular risk profile. Reported as mean value at each assessment time point.
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Concentration of High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline, Month 12, Month 24
Serum HDL-C concentration measured in millimoles per liter (mmol/L) using direct enzymatic assay after overnight fasting. Higher values indicate better cardiovascular risk profile. Reported as mean value at each assessment time point.
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Concentration of Fasting Plasma Glucose
Time frame: Baseline, Month 12, Month 24
Fasting plasma glucose concentration measured in millimoles per liter (mmol/L) using hexokinase method after at least 8 hours of fasting. Reported as mean value and number of participants with values ≥7.0 mmol/L at each assessment time point.
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Concentration of Glycated Hemoglobin (HbA1c)
Time frame: Baseline, Month 12, Month 24
HbA1c level measured as percentage (%) using high-performance liquid chromatography (HPLC) method standardized to National Glycohemoglobin Standardization Program (NGSP). Lower values indicate better glycemic control. Reported as mean value and number of participants with HbA1c ≥6.5% at each assessment time point.