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Finally, a radical addition of the hydroxide included in the Fe(III)OH complex forms a hydroxy-epoxide product and restores the active Fe(II) form

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Although we elected to address the issues in proposed 424.527 via rulemaking, we noted in the proposed rule that we retained the authority under section 1866(j)(3)(B) of the Act to establish and implement PPEO procedures via sub-regulatory guidance

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However, in healthy people with normal dietary habits, it is well-recognized that hyponatremia is very difficult to achieve ( EFSA 2010