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That shift is what cleared the path for the committee to formally review it

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)

These reasons, while understandable from a procedural standpoint, can be clinically and emotionally detrimental to a patient with Pernicious Anemia who is symptomatic and in need of treatment

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Vitamin B12 Vitamin B12 is essential for energy production and proper nerve function