Patients were ineligible if they lived in a long-term care
facility, had cancer or an inflammatory disorder
that required treatment in the previous 12 months,
or had major surgery in the previous 12 months.
All the inclusion and exclusion criteria are listed
in Table S1 in the Supplementary Appendix, available
with the full text of this article at NEJM.org.
The full protocol and statistical-analysis plan are
also available at NEJM.org.