The other studies I cite as comparative examples are mostly from newevidence.com, which provides tons and tons of oncology trial summaries categorized according to type, including breast cancer.
I do not have formal medical training and only an albeit rusty college-level understanding of statistics. However, I can say that I have done fairly extensive reading of oncology papers having dealt with cancer in my immediate family. In this regard, I can say that I have a certain familiarity with the clinical process and the statistical models and assumptions used.
Of course, bear in mind that this original design document is outdated and may have been amended since its submission. I don't have access to more up-to-date resources, unfortunately.
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