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We used the same set of claims and a charge inflation factor of 11.3 percent (1.11313) and the CCRs in the July 2025 OPSF, with an adjustment of 0.956081 (90 FR 37227), to reflect relative changes in cost and charge inflation between CY 2025 and CY 2026, to model the final CY 2026 outliers at 1.0 percent of estimated total payments using a multiple threshold of 1.75 and a fixed dollar threshold of $6,225

Certificates of Analysis are provided to document analytical verification, purity assessment, and quality control procedures associated with each batch

The lack of comprehensive long-term studies necessitates a cautious approach to extended treatment protocols

The methylmalonyl-CoA mutase pathway processes only this minor component of overall fat metabolism

While the primate studies found no evidence of ectopic fat accumulation in the liver or arterial walls, the concern remains valid for larger-scale or longer-duration use