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10.1038/s41586-019-1705-2 5 BesserE.GelfandA.ProcacciaS.BermanP.MeiriD

Significant results are often only observed after (mostly unplanned) post-hoc stratification [199, 200], while pre-registered stratified analyses did not show effects [201]

In some embodiments, the use of an appropriate thermosetting polymer and an appropriate copolymer (e.g., a gelling agent) in combination with a specific pH range for the formulation allows for high temperature sterilization of formulations described with substantially no degradation of the therapeutic agent or the polymeric excipients

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