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This study was performed in line with the principles of the Helsinki Declaration of 1975. The study protocol, informed consent documents, and all relevant materials were reviewed and approved by the Mass General Brigham Institutional Review Board (IRB) (Protocol 2019P000837, approved 12\/04\/2019). This clinical trial received an investigational device exemption (IDE) from the US FDA #G200040 Written informed consent was obtained from all subjects or, when subjects were unable to provide consent, from their legally authorized representatives (LAR). Subjects, or their legally authorized representatives, signed informed consent forms which stated that the results of the research study may be published in a medical journal.","order":1,"name":"Ethics","label":"Ethics approval and consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Subjects, or their legally authorized representatives, signed informed consent forms which stated that the results of the research study may be published in a medical journal.","order":2,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"JAP, JOH, JL, and ATR have licensed the investigational CDSS to the Nihon Kohden Corporation. NS has received DoD funding for unrelated work. NS has received consulting fees from Haemeonetics and Zimmer Biomet. NS has a patent issued with MIT Lincoln Labs for unrelated work. JL has received grant funding from Beckman Coulter, Inc. and the Massachusetts Department of Public Health for unrelated work. JL has received consulting fees from Vertex Pharmaceuticals for unrelated work. JL holds an unpaid volunteer leadership role with Health Tech Without Borders, Inc. IEK, MM, LL, AOC and HSA have no conflicts of interest to report.","order":3,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"513"}}