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705-1.031) in the per-protocol analysis. Sensitivity analyses after excluding patients using the exclusion criteria (a follow-up duration 24 and 36 months, respectively, patients with incretin-based therapies during follow-up, and patients enrolled during 2 different periods of 1999-2003 and 2004-2009) consistently showed a neutral effect. However, metformin initiators had a significantly higher risk of leukemia in the per-protocol analyses when censoring patients at a time without regular follow-up. Metformin use has an overal