The steering committee, composed of the principal
investigator at each clinical site and at the
data coordinating center and the project scientist
from the sponsor (NIDDK), designed and implemented
the study. The data coordinating center
accumulated data in a central database during the
study and performed data analyses according to a
prespecified plan developed by the biostatisticians
at the data coordinating center and approved by
the steering committee and the data and safety
monitoring board. The study investigators, who
had access to all data analyses and wrote the
manuscript, attest to the veracity and completeness
of the data and the fidelity of the study to the
protocol. The decision to submit the manuscript
for publication was made by the steering committee,
with no restrictions imposed by the sponsor.
The data were analyzed by two members of the
writing group. The drugs used in the study were
donated by pharmaceutical manufacturers (listed
at the end of the article), which had no role
in the study design, data accrual, data analysis,
or manuscript preparation.