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All medication decisions are made after evaluation and are supervised by a licensed provider
The dysesthesia safety signal and the novel triple-agonist mechanism might prompt the FDA to seek external input
Cardiovascular Outcomes The effects of acarbose on cardiovascular outcomes were investigated in the Stop Non-Insulin-Dependent Diabetes Mellitus (STOP-NIDDM) trial (Chiasson et al., 2003), recruiting patients with impaired glucose tolerance randomly allocated to acarbose or placebo over a mean follow-up of 3.3 years
(All definitions of adjudicated events are provided in Table S4 in the Supplementary Appendix.) Statistical Analysis The prespecified statistical analysis plan is available with the protocol at NEJM.org
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