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A deficiency or lack of Vitamin B12 is quite common in the over 65s, those diagnosed with pernicious anaemia, and in anyone who follows a vegan, strict vegetarian, or extreme/fad/restricted diet for a long time without taking a B12 supplement or eating fortified foods

Some people try to eyeball it, they figure "close enough" works, but it doesn't

Has stress or sleep quality changed

It is clear

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For example, other drug makers might pursue this approach going forward, compared to the more rigorous FDA approval pathway