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chronic liver disease and hepatitis may present with elevated levels Renal impairment : Reduced clearance can contribute to accumulation, though this is rarely clinically significant Solid tumours : Certain malignancies, particularly hepatocellular carcinoma and metastatic disease, may elevate B12 levels [3] Evidence suggests that unexplained markedly elevated B12 levels without supplementation may sometimes be associated with underlying disease

doi: 10.1016/j.cell.2017.12.030 97 HardimanO.Al-ChalabiA.ChioA.CorrE

An ensuing low-grade thyroid dysfunction has been associated with bipolar disorder and most likely influences both the clinical presentation and the treatment response (179, 180)

Rather, it reflects the evidence available, how the compound is manufactured and distributed, and whether regulators believe it should be available through established medical channels