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[Correspondence] The CONFIDeNT trial – Authors’ reply

We are pleased that the CONFIDeNT study1 has attracted the interest of several correspondents. Philip Hartley and colleagues point out the discrepancy between the prespecified primary and secondary outcomes detailed on the clinical registry (ISCTRN) and those in the final Article. We have reviewed these discrepancies and concede that we failed to fully update the trial registry. Nevertheless, we can confirm that all recorded study outcomes were fully reported and that these are entirely consistent with the final (Research Ethics Committee approved) trial protocol and those prespecified in the study analysis plan before unblinding of data.