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While we acknowledge concerns that a hospital may not have the opportunity to respond to performance results between the implementation of the star cap and the 1-star reduction, we note that the Safety of Care measure group and its component measures have been a prominent part of the Overall Hospital Quality Star Rating since its inception, with hospitals' Safety of Care performance already contributing substantially to their Overall Hospital Quality Star Rating

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Finally, descriptive statistics were used to analyze safety endpoints of the randomized treatments in all participants that were exposed to at least one dose [1]

V., Goldacre, R., Skingsley, A., Conlon, C

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the agency cited concerns over potential immune reactions, manufacturing impurities, and a lack of human safety data