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In summary, the Purolea inspection uncovered two interrelated problems: (1) classical cGMP failures e.g
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doi: 10.1056/NEJMOA1607141/SUPPL_FILE/NEJMOA1607141_DISCLOSURES.PDF 15 HolmanRRBethelMAMentzRJThompsonVPLokhnyginaYBuseJBet al
Using doses below the therapeutic threshold may provide insufficient metabolic benefit, essentially exposing patients to medication risks without meaningful clinical gain
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