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While historically listed with an "unknown status," recent data releases in late 2025 and early 2026 have clarified the safety profile that helped justify the Category 1 reclassification. Study Design: A randomized, placebo-controlled, double-blind Phase 1 pilot study

PubMed laboratory research record [PMID: 9046051] PubMed record related to this compound for laboratory literature review

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For patients who want to transition from a compounded product to an FDA-approved one, both clinicians cautioned that the process isnt always straightforward, as it may not be clear what dose a patient on a compounded product had been taking

PMID 3046314