Study Design and Oversight
This study was conducted at 88 centers in nine countries (for details, see the Supplementary Appendix, available with the full text of this article at NEJM.org). Amgen sponsored and designed the trial (the latter in collaboration with the last author) and was responsible for data collection and analysis. Local institutional review boards approved the study protocol, which is available at NEJM.org. The first draft of the manuscript was written by the first and last authors, and Amgen provided editorial assistance. All the coauthors participated in subsequent revisions of the manuscript. The academic authors had full access to the data and vouch for their accuracy and completeness, for the analyses as presented, and for the fidelity of the study to the trial protocol.
Study Design and Oversight This study was conducted at 88 centers in nine countries (for details, see the Supplementary Appendix, available with the full text of this article at NEJM.org). Amgen sponsored and designed the trial (the latter in collaboration with the last author) and was responsible for data collection and analysis. Local institutional review boards approved the study protocol, which is available at NEJM.org. The first draft of the manuscript was written by the first and last authors, and Amgen provided editorial assistance. All the coauthors participated in subsequent revisions of the manuscript. The academic authors had full access to the data and vouch for their accuracy and completeness, for the analyses as presented, and for the fidelity of the study to the trial protocol.
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