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This clinical trial history provides access to a published pharmacokinetic and safety dataset, including human tolerability data that is unusual for a research-stage metabolic peptide

For many patients, it may offer a middle ground between conservative care and invasive surgery

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We believe this clarification is also consistent with the policy articulated in the CY 2025 PFS proposed rule and throughout this final rule to continue the shortage reduction clock once it begins in other scenarios such as for drugs that fluctuate on and off the shortage list within a timespan less than four full calendar quarters