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It is a recommendation to FDA, not a rule

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Proof for this effect in human beings is, however, wanting, and therefore more evidence would be needed

The phase 2 trial record for NCT03856047 prespecifies exactly how timing deviations were handled

In brief, HUVECs were lysed in the Co-IP buffer containing 20 mM Tris-HCl (pH7.5), 100 mM NaCl, 0.5 mM EDTA, 0.5% NP-40, 0.5 mM PMSF, 0.5% protease inhibitor cocktail on ice for 20 min