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To demonstrate substantial clinical improvement over currently available treatments, we stated that we consider supporting evidence, preferably published peer-reviewed clinical trials, that show improved clinical outcomes, such as reduction in mortality, complications, subsequent interventions, future hospitalizations, recovery time, pain, or a more rapid beneficial resolution of the disease process compared to the standard of care

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Nowotny, K., Schroter, D., Schreiner, M

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PMID 3046314