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He has received grant support from General Electric, Gilead Sciences, AstraZeneca, Endra Life Sciences, financial support from Pfizer, Inc., in connection with this research and the development of this manuscript. His institution has had research contracts with Intercept, Pfizer, Galectin, Exact Sciences, Inventiva, Enanta, Shire, Gilead, Allergan, Celgene, Galmed, Rhythm, Madrigal, and Genentech. AB: None. KT: Employee and shareholder of Pfizer Inc. MJB:Grant support from Center for Disease Control (CDC), National Institute for Occupational Safety and Health (NIOSH), National Institute of Health (NIH) (NICATS and National Heart, Lung, and Blood Institute (NHLBI)), Patient-Centered Outcomes Research Institute (PCORI) (PaTH) and industry support from Owkin, Inc. MJB also is founder and has equity in SpIntellx, Inc. NC: None. CHC: none. SAF: none. DEF: none. DEF: none. HLK: none. RM: none. AP: none. JCS: Research grant contracts with Target Pharma Inc and Grifols. DAW: Consultant for Community Health Focus, Inc. and Swing Therapeutics, Inc. WTD: none. SKA: none. FN: Employee and shareholder of Pfizer Inc. MA: Employee and shareholder of Pfizer Inc. RHD: Employee and shareholder of Pfizer Inc. EM: Employee and shareholder of Pfizer Inc. KM: Grant support from NIH, PCORI, the American Heart Association, Eli Lilly, financial support from Pfizer, Inc., in connection with this research and the development of this manuscript and Janssen Pharmaceuticals.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All procedures performed in this study were in accordance with the ethical standards of the institutional and\/or national research committee(s) and with the Helsinki Declaration (as revised in 2013). Publication of this case report and accompanying images was waived from patient consent according to the University of Pittsburgh Human Research Protection Office, Johns Hopkins Medicine Institutional Review Boards, The Ohio State University Office of Responsible Research, University of Michigan Medical School Institutional Review Board (IRBMED), Geisinger Institutional Review Board, Institutional Review Board, Temple University Office of Research Integrity and Compliance, Pennsylvania State University Human Research Protection Program, University of Florida Institutional Review Board, and the Baylor University Human Research Protection Program.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"The institutional review board at each participating site approved the study or deemed it eligible for waiver of informed consent as follows: <i>University of Pittsburgh Human Research Protection Office<\/i> The existing IRB protocol [STUDY19080151] in the University of Pittsburgh\u2019s Human Research Protection Office provides regulatory oversight for specific uses of the PCORnet Common Data Model, including \u201censuring that the Pittsburgh PaTH sited can provide high quality research data to support IRB authorized studies.\u201d The PCORnet IRB was granted expedited approval, waiver of HIPAA authorization, and waiver of the consent process. The study described in this manuscript involved a data-only query and did not require an additional IRB application to the Human Research Protection Office as it falls under the existing \u201cUse of PaTH Federated Research Network\u201d IRB and is considered no greater than minimal risk. <i>Johns Hopkins Medicine Institutional Review Boards<\/i> The existing IRB protocol [IRB00051881: \u201cPaTH Clinical Data Research Network (CDRN) Health Systems Database for Analysis of De-Identified Data,\u201d] specifies, \u201cA waiver of consent was granted based on the following criteria: (1) the research involves no more than minimal risk to subjects; (2) the waiver will not adversely affect the rights and welfare of the subjects; (3) the research could not be practicably carried out without the waiver; and (4) the IRB will advise you if it is appropriate for participants to be provided with additional pertinent information after participation.\u201d <i>The Ohio State University Office of Responsible Research<\/i> The Ohio State University Office of Responsible Research maintains an approved protocol for PCORnet [Study: 2019H0123, \u201cPCORI\/PCORnet at Ohio State\u2014Use of PaTH Federated Research Network\u201d] that allows \u201cresearchers to request and access aggregate, de-identified and coded limited datasets without project specific IRB protocol approval or determination of exemption, and identifiable datasets inclusive of protected health information (PHI) with appropriate project-specific IRB review and approval.\u201d There is a Waiver of Consent for the PCORnet IRB. <i>University of Michigan Medical School Institutional Review Board (IRBMED)<\/i> \u201cThe IRBMED determined that the proposed research repository does not meet the definition of \u2018research involving human subjects\u2019 under the Common Rule or FDA regulations. As such, no IRB oversight is required.\u201d <i>Geisinger Institutional Review Board<\/i> The Geisinger Institutional Review Board has approved IRB #: 2015\u2013180,\u201cClinical Data Analysis,\u201d which applied to this study and states that \u201cthe proposal does not appear to involve \u2018human subjects\u2019 as defined in 45 CFR 46. 102(f); and therefore, is not subject to oversight by the Institutional Review Board.\u201d <i>Institutional Review Board, Temple University Office of Research Integrity and Compliance<\/i> Protocol #24007\u20130005 for \u201cPCORI Clinical Data Research Network (CDRN) Health Systems Database for Analysis of De-Identified Data\u201d applied to this study and has been determined by the IRB to be \u201cnot human subjects research.\u201d There was no requirement for IRB oversight or patient consent. <i>Pennsylvania State University Human Research Protection Program<\/i> STUDY0000643, \u201cPaTH towards a Learning Health System for the Mid- Atlantic Region-PCORI Clinical Data Research Network (CDRN) Health Systems Database for Analysis of De-Identified Data,\u201d covers the research activities of this study and states \u201cThe Human Subjects Protection Office determined that the proposed activity, as described in the above-referenced submission, does not meet the definition of human subject research as defined in 45 CFR 46.102(d) and\/or (f). Institutional Review Board (IRB) review and approval is not required.\u201d <i>University of Florida Institutional Review Board<\/i> Per IRB# IRB202003203, \u201cThis study is approved as exempt because it poses minimal risk and is approved under the following exempt category\/categories: (4)(iii) Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: (iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of \u201chealth care operations\u201d or \u201cresearch\u201d as those terms are defined at 45 CFR 164.501 or for \u201cpublic health activities and purposes\u201d as described under 45 CFR 164.512(b).\u201d <i>Baylor University Human Research Protection Program<\/i> IRB 021-130 \u201cNon-Alcoholic Steatohepatitis (NASH) Risk Stratification Reference Number: 360000\u201d was granted expedited review and approval \u201cas it involves no greater than minimal risk to the subjects and fits into the following category from the 1998 approved list: Category 5: Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).\u201d Additionally, \u201cThe IRB has waived the requirement for informed consent based on 45 CFR 46.116 (f). The IRB has 1) waived the requirement for authorization based on 45 CFR 164.512 (i) (2) (ii) and 2) determined the use of existing protected health information is necessary to do the research.\u201d","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}