The steering committee (see the Supplementary
Appendix, available with the full text of this
article at NEJM.org), chaired by the principal
investigators, designed the trial and prespecified
the statistical analysis plan. The members of the
steering committee vouch for the completeness
and accuracy of the data and analyses reported
and for the adherence of the trial to the protocol,
available at NEJM.org. The first author, who
was the chair of the writing committee, wrote
the first draft of the manuscript; all the members
of the writing committee made revisions
and made the decision to submit the manuscript
for publication.