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Comment: A few commenters expressed their support for the proposal to exclude ACOs with fewer than 5,000 assigned beneficiaries in the benchmark years from additional opportunities for low revenue ACOs to share in savings because this policy overall may increase participation by additional new, renewing, or re-entering ACOs

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This extensive safety database enables researchers to focus on scientific objectives rather than safety concerns, while the well-characterized safety profile facilitates regulatory approval for research protocols and institutional review board assessments for experimental studies