Response:

We would like to thank Dr Kawakubo et al1 for the comments on our article.2 The sample size for this superiority randomized trial was performed for a 2-sided comparison at 80% power, type I error rate of 0.05, based on the primary outcome measure of adverse rates. Therefore, the null hypothesis (H0) was defined as there being no significant difference in adverse event rates between EUS-guided biliary drainage (EUS-BD) and ERCP, and the alternative hypothesis (H1) was defined as a significant difference in adverse event rates between the 2 treatment modalities, without the direction of the difference being specified.

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