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Patients were identified by chart review and were divided into two subgroups: early-therapy (begun within 12 months, mean 3 months, of starting insulin) and late therapy (begun more than 12 months, mean 168 months, after starting insulin)

doi: 10.1038/s41574-019-0228-0 69 SalimS

November: 1-13., [51]Analytical Procedures and Methods Validation for Drugs and Biologics: Chemistry, Manufacturing, and Controls, Federal Register (Notices)