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During this time other work also evaluated the effects of aggregated human gamma globulin, formed during commercial preparations and product variations as a function of manufacture source

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The FDAs stated concerns are: (1) theoretical risk of allergic reactions with repeated peptide administration, (2) quality control concerns about compounding purity and consistency, and (3) no Phase 1-3 trials conducted under FDA oversight

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Understanding which side effects come from which component helps in managing tolerance and making informed decisions