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High-risk groups who should be considered for monitoring include: Patients taking metformin for more than three years Those on high-dose metformin (≥2g daily) Older adults (aged 65 years and above), who have reduced gastric acid production and lower B12 stores Patients with pre-existing risk factors for B12 deficiency, including previous gastric surgery, pernicious anaemia, or inflammatory bowel disease Individuals following vegan or vegetarian diets with limited dietary B12 intake Those taking acid-suppressing medications (proton pump inhibitors or H2-receptor antagonists) Patients with symptoms suggestive of B12 deficiency Patients with unexplained anaemia or neuropathy The frequency of monitoring should be guided by clinical judgement and local pathways, with consideration of individual risk factors

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ACKNOWLEDGMENTS We thank all the investigators and clinical study staff that executed the ReCePI study and the DSMB members that provided study oversight (Dr