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. 2003 Oct 20;2003(4):CD004000. doi: 10.1002/14651858.CD004000

Harada 1991B(2).

Study characteristics
Methods Unit of randomisation: child 
Method of randomisation: centralised randomisation
Timing of randomisation: at diagnosis 
Blinding: unclear
Power calculation: nil
Number of centres: not stated. However the paper states "multicentre"
295 patients randomised in all 3 comparisons
6 exclusions at 30 days, 17 at 60 days and 18 at 1 year
289 patients analysed at 30 days, 278 at 60 days and 277 at a year
Source of funding: not stated
Participants Children within 7 days of the onset of symptoms. Diagnostic criteria not stated
Age: under 4 years
Location: Japan
Timing and duration: 1985‐1986
Interventions 100 mg/kg/day pepsin‐treated IVIG + 50 mg/kg/day oral aspirin
Control: 50 mg/kg/day oral aspirin
Duration: 5 days (IVIG), aspirin duration not stated
Outcomes Coronay artery abnormalities
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate