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To demonstrate that the RNS in both formulations can be sterilized with a typical EtO cycle and provides CCI over time as intended, West conducted a functionality study over time in partnership with well-known industry experts from the pre-filled syringe vendor industry and sterilization experts

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For instance, in phase 2 trials of SEMA 2.4 g, a substantial reduction in placebo response was observed in composite endpoints of MASH and fibrosis

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