We want to commend the authors on addressing two challenging issues that are of fundamental importance to the developers of innovative pharmaceutical products,. These two issues are related, but are of a different nature. Simply stated, the first issue deals with the level of evidence needed to include additional endpoints in a product label,. The second issue deals with the level of evidence and thus the required sample size when a new treatment needs to demonstrate effect on multiple coprimary endpoints in order to be acceptable In what follows, we will comment on the points raised by the authors in these two areas. In addition, we will offer some additional insight on the multiple coprimary endpoints issue. Most of our comments related to Section 3 are outside the scope of the original paper. We include them in this commentary with the hope that these comments will help stimulate additional interest and research on this topic.
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