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The trials demonstrated that AOD-9604 displayed a very good safety and tolerability profile indistinguishable from placebo

Specifically, and as shown in Table 60, we are clarifying in this final rule that CMS will apply the greatest rebate reduction to the first applicable period that a drug or biological is described as currently in shortage regardless of whether the drug or biological meets the definition of a Part D rebatable drug or owes a rebate amount, starting with the applicable period that begins October 1, 2022

In the CY 2024 PFS rule (88 FR 79239 through 79240), we codified these policies in regulations at 410.10(l) and 410.57(c)

The pain will often worsen when moving or touching the joint, and some patients have difficulty moving the joint due to limited range of motion