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However, the superior efficacy often associated with injectable peptides and the established infrastructure for injection devices suggest autoinjector s and pens will remain central for high-efficacy treatment

For the trial product estimand, continuous endpoint analyses were conducted using a mixed model for repeated measures with randomized treatment as a factor and baseline endpoint value as a covariate

### Regulatory Status and Availability **AOD-9604:** - Never received FDA approval for any indication - Classified by the FDA as a **Category 2 bulk drug substance** not eligible for compounding under Section 503B - Removed from many international peptide supplier platforms (including Alibaba and related marketplaces) - Legal status varies by country