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American Journal of Respiratory and Critical Care Medicine 179 , 903913, doi: 10.1164/rccm.200808-1274OC (2009)

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As of April 2026, all new OROS lyophilized product batches are tested by independent ISO/IEC 17025-accredited laboratories in the United States

The pivotal RECONNECT Phase 3 trials, two identically designed randomized, double-blind, placebo-controlled studies involving 1,267 women, established the peptide's therapeutic benefit