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10.1097/00002517-199206000-00004 146 LefebvreV
Yes, a clinical review is required to determine your eligibility

Z.uranN.et al (2022)

Reduce postoperative pain or pain after medical procedures

They pointed out that the FDA had not released specific safety data to back up its claims

Finally, the above approach to evaluate organoid-derived FVII function suggests that although these experiments are not specific for FVII activity per se, supernatants (supplemented with vitamin K) show hemostatic potential due to the secretion of serine proteases (probably gamma-carboxylated) into the conditioned medium that mimic the FVII effect
