Dissemination plans {31a}
A final clinical investigation report (CIR) prepared by the sponsor will be completed, even if the investigation is prematurely terminated. All publications and presentations will be based upon the CIR. Publication of trial results will be jointly decided by the sponsor and trial investigators. Results will be disseminated via the traditional academic route and to the lay and professional press. Trial results will also be fed back to participating sites. Authorship and degree of involvement will be agreed with the investigators according to criteria published by the International Committee of Medical Journal Editors. While the sponsor has the right to use the results for registration, for internal presentation and for promotion, the investigators will be asked to comment upon and approve of any such use.