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The regulation itself states that available data are inadequate to demonstrate the safety or efficacy of any drug product compounded using the substances listed there, or to establish general recognition of safety or effectiveness

In the randomized placebo-controlled HOME trial of 390 adults with type 2 diabetes (de Jager and colleagues, Long term treatment with metformin in patients with type 2 diabetes and risk of vitamin B-12 deficiency, BMJ, 2010), metformin lowered serum B12 by a mean of 19 percent over 4.3 years

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