Here is the design of a clinical trial:

Official Title: Kawasaki Disease Center, Kaohsiung Chang Gung Memorial Hospital, Taiwan

Included conditions:
- Kawasaki Disease

Study Armgroups:
- {'label': 'IVIG only', 'type': 'EXPERIMENTAL', 'description': 'All patients will receive IVIG (2g/kg) in 10-12 hours alone, without high-dose aspirin. After fever subsides, low-dose aspirin (3-5mg/kg/day) will be prescribed until 6-8 weeks.', 'interventionNames': ['Other: IVIG only']}
- {'label': 'IVIG and Aspirin', 'type': 'ACTIVE_COMPARATOR', 'description': 'All patients will receive IVIG (2g/kg) in 10-12 hours plus high-dose aspirin (80-100mg/kg/day, divided into four doses) till fever subside. After fever subsides, low-dose aspirin (3-5mg/kg/day) will be prescribed until 6-8 weeks.', 'interventionNames': ['Other: IVIG and Aspirin']}

Interventions:
- {'type': 'OTHER', 'name': 'IVIG only', 'description': 'All patients will receive IVIG (2g/kg) in 10-12 hours alone, without high-dose aspirin.', 'armGroupLabels': ['IVIG only']}
- {'type': 'OTHER', 'name': 'IVIG and Aspirin', 'description': 'All patients will receive IVIG (2g/kg) in 10-12 hours plus high-dose aspirin (80-100mg/kg/day, divided into four doses) till fever subside.', 'armGroupLabels': ['IVIG and Aspirin']}

Primary Outcomes:
- {'measure': 'coronary artery lesions', 'timeFrame': '8 weeks'}

Please estimate the sample size based on the assumption: 
Type I error rate (α) is 0.05, Type II error rate (β) is 0.2, and the clinically meaningful difference (δ) is -0.1. A maximum dropout rate of 10% is assumed.
Sample size
        The sample size determination is based on the results of the retrospective data (24). The estimated proportions of CAL are 17% after IVIG treatment combined with high-dose aspirin and 15.4% after IVIG alone. We consider a difference less than 10% as having no clinical significance. The following contents are the statistical basis for estimating sample size in this trial:\documentclass[12pt]{minimal}
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				\begin{document}$$ {\mathrm{H}}_0:{\mathrm{P}}_{\mathrm{T}}-{\mathrm{P}}_{\mathrm{S}}\leqq \updelta $$\end{document}H0:PT-PSâ¦Î´\documentclass[12pt]{minimal}
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				\begin{document}$$ {\mathrm{H}}_{\mathrm{A}}:{\mathrm{P}}_{\mathrm{T}}-{\mathrm{P}}_{\mathrm{S}}>\updelta $$\end{document}HA:PT-PS>Î´
        PT: CAL-free rate in test group =0.846.
        PS: CAL-free rate in standard group =0.83.
        Î´ = â0.1.\documentclass[12pt]{minimal}
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				\begin{document}$$ n=\frac{{\left({Z}_{\alpha }+{Z}_{\beta}\right)}^2}{{\left(\varepsilon -\delta \right)}^2}\left[{P}_T\left(1-{P}_T\right)+{P}_S\left(1-{P}_S\right)\right] $$\end{document}n=ZÎ±+ZÎ²2ÎµâÎ´2PT1âPT+PS1âPS
        Assuming that the type I and type II error rates are Î±â=â0.05 and Î²â=â0.2, respectively, the clinically meaningful difference Î´ is ââ0.1. The CAL-free rate of the test group (IVIG alone) PT is 0.846 while that of the standard group (IVIG + high dose aspirin) PS is 0.83. DefineÂ Îµâ=âPTâââPS. Assuming the sample sizes of the two groups are equal, each group for the non-inferiority trial must have 125 patients. In order to offset a maximum dropout of 10%, 139 patients are needed for each group. Therefore, a total sample size of 278 patients is required for this trial.