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The statute authorizes the Secretary to make exceptions to the 2 times rule in unusual cases, such as for low-volume items and services (but the Secretary may not make such an exception in the case of a drug or biological that has been designated as an orphan drug under section 526 of the Federal Food, Drug, and Cosmetic Act)

6 Conclusion A growing body of experimental and clinical data highlights the important role of the RAS in the pathophysiology of mood disorders

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