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This prespecified endpoint occurred alongside major adverse CV events and all-cause mortality reductions, suggesting a comprehensive cardio-renal-metabolic effect

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2.1.1.5 Monitoring - Continuously monitor the parameters evaluated during screening

In their report from 2003 Voedingsnormen: vitamine B6, foliumzuur en vitamine B12 the council joined expert commissions from the American Institute of Medicine and the Scientific Committee for Human Food from the European Union, who had already reported 3 years earlier that toxicity from high dose vitamin B12 poses no real danger

2006 Apr;97(2):303-9 (2) Shustanova TA, Bondarenko TI, Milyutina NP, Mikhaleva II