Table 3 The five elements of the outcomes
Domain | Specific measurement | Specific metric | Method of aggregation | Time-points |
|---|---|---|---|---|
Primary outcome | ||||
 Stable angina symptom score | Symptom score standard classification [22] | Difference between two groups | Proportion | Baseline, 28 days after treatment |
Secondary outcomes | ||||
 ECG parameters | Classification of 12-lead ECG improvement [23] | Difference between two groups | Proportion | Baseline, 28 days after treatment |
 SAQ scores | SAQ [24] | Difference in the change between groups | Mean/ median | Baseline, 28 days after treatment |
 Nitroglycerin consumption | Count | Compare the difference between groups | Median | Baseline, 28 days after treatment |
Safety outcomes | ||||
 Vital signs | Heart rate, respiration, body temperature, blood pressure | Compare the difference between groups | Mean/ median | Run-in period, baseline, 28 days after treatment |
 Clinical laboratory tests | Routine blood test, routine urinalysis, serum biochemistry, blood coagulation index, and fasting blood glucose | Compare the difference between groups | Mean/ median | Baseline, 28 days after treatment |
 AEs, SAEs | Common Terminology Criteria for AEs version 4.03. | Compare the difference between groups | Proportion | Baseline, 28 days after treatment |