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No peer-reviewed human clinical trial data on 5-Amino-1MQ efficacy or safety appears to be available in published literature, representing a significant evidence gap

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One commenter asked the agency to evaluate the evidence and appropriateness of enabling audio-only treatment initiation of methadone, including by partnering with external research organizations to assess this topic, improve parity in flexibilities for buprenorphine and methadone, and reduce stigma around methadone