Ethical approval Ethical approval for these studies was obtained from the University of Central Lancashires Faculty of Health Research Ethics Committee which accepted that the study had been granted exemption by the Department of Healths National Information Governance Board from the need to obtain informed consent from individuals retrospectively to participate in the mortality study
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Under these assumptions, the 6000-patient SMART design will provide 80% power (two-sided = 0.025 to account for two co-primary outcomes) to detect increases in Reach of 6.2%, 2.8%, and 3.6% from assumed control group percentages of 10%, 5%, and 10%, for the AAC-Out vs
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