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BD follows local regulatory requirements relating to clinical trial registration and results disclosure. In the United States, BD complies with the requirements of the Food and Drug Administration Amendments Act (FDAAA) of 2007 to both register and to post results of our applicable clinical trials (as defined in the FDAAA).
BD commits to seek the publication of the results of our completed applicable clinical trials on any marketed product in peer-reviewed scientific literature, regardless of the trial's outcome. BD supports recognized standards concerning authorship and publication, including those of the International Committee of Medical Journal Editors (ICMJE) and Consolidated Standards of Reporting Trials (CONSORT).
BD will provide the final statistical reports of protocol-derived outcomes to external authors. BD reserves the right to review and comment on draft abstracts, manuscripts, presentations and other communications by external investigators regarding BD-sponsored trials, prior to their submission or public disclosure, to protect intellectual property and confidential information. As study sponsor, BD does not approve or veto such publications.