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After reconstitution, the solution should remain refrigerated at 28C and protected from freeze-thaw cycles, which can cause peptide aggregation and measurable loss of bioactivity
Individuals with a history of thromboembolic disorders should also be carefully evaluated prior to treatment, especially when HCG is used as part of ovulation induction protocols in women, as it may increase thrombotic risk through hormone elevation
Final classification depends on the committee's recommendation and the FDA's subsequent rulemaking
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