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High levels of S1P in fact have been found in the peritoneal environment of women suffering of endometriosis, showing the capability to induce differentiation of macrophages into CD163 + M2 type, which secretes pro-inflammatory cytokines such as IL-6, COX-2, and TGF-β contributing to the inflammation and fibrosis underlying these lesions [45]

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On July 24, 2026 the committee voted 6–7 against recommending it for the 503A bulks list — a one-vote margin and the only rejection across the two-day meeting