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. 2022 Jan 21;23:65. doi: 10.1186/s13063-021-05914-1

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

ECG electrocardiogram, SAQ Seattle Angina Questionnaire