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Second, compounded products do not undergo FDA review for safety, efficacy, or manufacturing quality
If untreated, they may cause intestinal tissue to die and can lead to abdominal infections
Mrtensson, J., Jain, A., & Meister, A
Anyone considering an emerging option should understand it as potentially helpful for some people in some ways, not as a guaranteed solution
2.4.3 Definition of Analysis Sets and Statistical Analysis of Endpoints PK, PD, and safety assessments were based on all subjects who received at least one dose of the study drug
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