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Lenz, A

No adverse effects were reported, but rigorous, large-scale trials are lacking

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Che H, Wang Y, Li H, Li Y, Sahil A, Lv J, Liu Y, Yang Z, Dong R, Xue H, Wang L

SEACs proposals for medical devices include a 13.5-year derogation after entry into force (EiF) for implantable medical devices, including medical implants and meshes, and invasive medical devices, such as tubes and catheters and polychlorotrifluoroethylene (PCTFE)-based packaging for medical devices

Document dosing rationales (route, concentration, frequency) and use pilot results to set dose escalation or fixeddose arms in the main study