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There have even been a number of published case reports detailing how certain suspected cases of HELLP syndrome actually end up being extreme vitamin B12 deficiency rather than typical preeclampsia

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In published preclinical research, 5-Amino-1MQ has been administered across multiple model systems with varying routes documented in the literature (PMID 28121423, PMID 33645410, PMID 35013352, PMID 39067875)

The agency said such discrepancies raise concerns about the safety of the trial subjects and the reliability of the trial data.