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Table 1 Trial process chart

From: Danhong injection in the treatment of chronic stable angina: study protocol for a randomized controlled trial

Period Run-in period Treatment period Follow-up period
Day −7 0 7 14 30 60 90
Informed consent × ×      
Inclusion or exclusion criteria × ×      
Medical history × ×      
Medical examination ×       
Combined disease treatment × × × × × × ×
Outcome measures:        
Proportion of patients who have a clinically significant change as defined by Seattle Angina Questionnaire: angina frequency score   ×    × × ×
Symptom questionnaire of traditional Chinese medicine   × × × × × ×
The other four Seattle Angina Questionnaire scales   × × × × × ×
Frequency of anginal attack per week × × × × × × ×
Canadian Cardiovascular Society grade   × × × × × ×
Consumption of short-acting nitrates × × × × × × ×
Electrocardiogram   × × × × × ×
Serum lipids   ×   ×    
High-sensitivity C-reactive protein   ×   ×    
Platelet aggregation rate   ×   ×    
New-onset major vascular events        ×
Overall mortality        ×
Incidence of severe haemorrhage        ×
Incidence of moderate haemorrhage        ×
Adverse and serious adverse events    × × × × ×
Exercise tolerance test (if necessary after 1st interim analysis)   ×   ×    
Profiles of micro-RNA in 60 patients in certain centres   ×   ×    ×
Profiles of mRNA in 60 patients in certain centres   ×   ×    ×