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The allowance for investigators to use all available information (for example, concomitant medication) to assess glycemic category was primarily included to account for scenarios in which glucose-lowering medications were initiated during the trial that would confound glycemic category assessment if based purely on fasting plasma glucose or HbA 1c levels (for example, if a patient developed diabetes during the study and received a glucose-lowering drug that resulted in their glucose level being below the American Diabetes Association threshold for type 2 diabetes diagnosis)

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Benefits: It promotes healthy brain function, enhances nerve signaling, and supports cardiovascular health

Imaging and nerve studies are used for diagnosis and treatment may include orthotics, padding, injections or surgery

If no improvement occurs after 3-4 weeks at appropriate doses, product quality may be an issue, or the condition may not respond to this approach

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