Haha, OK, I'll say no more than 100. The reason for going that high is that with all those secondary endpoints they might want to adjust for multiplicity, and if you are doing a study like this you really really don't want to fail to achieve the primary endpoint. I'd say that's why most of the other studies have so many pariticipants, although you also need less in a single arm trial because you don't have to enrol a control arm as well.
Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-42
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