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Think of the drug approval process like building a house
doi:10.1155/2014/874610
In addition, further subgroup analyses for different ages and ADR also yielded negative results (Additional file 1: Fig S56)
[12] [1] As an IMP, its storage and handling are governed by Good Clinical Practice (GCP) guidelines, EU/UK GMP Annex 13 (Investigational Medicinal Products), and the specific trial protocol not by a publicly available regulatory document
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