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

Morikawa 1994(1).

Study characteristics
Methods Unit of randomisation: child
Method of randomisation: centralised
Timing of randomisation: time of diagnosis Blinding: yes (triple) 
Power calculation: yes (80% with 150 in each group)
Number of centres: 95
313 patients randomised
2 exclusions from the adverse effects analysis, 11 from the CAA analysis and 11 from the duration of fever analysis 
311 patients analysed for the adverse effects outcome, 299 patients analysed for the CAA outcome and 299 patients were analysed for the fever duration outcome
Source of funding: not stated
Participants Children within 9 days from the onset of symptoms and meeting the diagnostic criteria for Kawasaki disease as set by the CDC, New York (see the description of studies in the body of the review)
Age: less than 6 years old
Location: Japan
Timing and duration: 1991‐1993
Interventions 200 mg/kg/day of polyethyleneglycol‐treated human immunoglobulin
VS
400 mg/kg/day of IV polyethyleneglycol‐treated human immunoglobulin
Duration: 5 days
Outcomes Coronary artery abnormalities
Adverse effects
Duration of fever
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate