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[Correspondence] Nanoliposomal irinotecan in metastatic pancreatic cancer – Authors’ reply

We appreciate the work of Ioan Milosevic and colleagues in their pursuit of accountability in clinical trial reporting. On behalf of all the authors of the NAPOLI-1 study,1 we would like to clarify that all endpoints, primary and secondary including safety, reported in our paper were prespecified and designated as such in the study protocol and statistical analysis plan. As part of our submission to The Lancet, we submitted both of these documents and, as part of the review process, a completed CONSORT checklist for the editors and reviewers.