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[Correspondence] REGULATE-PCI trial – Author’s reply

We note the Correspondence by Eirion Slade and colleagues stating that we reported 21 endpoints that were not prespecified in our Article.1 Their assertion is not correct. Our protocol, dated Oct 11, 2012, and statistical analysis plan, dated July 26, 2013, delineated secondary composite endpoints that were to be subjected to hierarchical closed testing to preserve overall type I error if the difference in the primary endpoint was statistically significant. That statistical analysis plan also specified exploratory tertiary endpoints, for which significance testing would be done but no superiority claimed even if nominal alpha levels were achieved; these endpoints are those included within the Article’s tables.