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We further excluded individuals with a history of treatment with insulin before their initial prescription for a non-insulin glucose-lowering drug (since insulin therapy at baseline is considered for patients with advanced disease), women with a history of polycystic ovary syndrome or gestational diabetes, and individuals with type 1 diabetes

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This isn't a conservative estimate

PubMed Central , Journal of Biological Chemistry , vol

Blinding was double-blind and placebo-controlled in both FLOW and LEADER