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Russell received consulting fees from Nestle, Lilly, Ferring, Alfasigma and Abbvie and speaker fees from Pfizer and Janssen. Marcus KH Auth received consulting fees from Dr Falk Pharma and travel bursaries from Dr Falk Pharma and Abbott. David Gass and Andrew Freiberg declare that they have no conflicts of interest that might be relevant to the contents of this manuscript. Shield Therapeutics reviewed the manuscript for accuracy.","order":1,"name":"Ethics","label":"Conflicts of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors received no funding for this publication.","order":2,"name":"Ethics","label":"Financial Assistance","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Shield Therapeutics paid for medical writing assistance.","order":3,"name":"Ethics","label":"Funding","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The Protocol and informed consent form were submitted to and approved by the duly constituted Institutional Review Board \/Independent Ethics Committee for each site prior to initiation of the study.","order":4,"name":"Ethics","label":"Ethics Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study was conducted in accordance with the Declaration of Helsinki and with all applicable laws and regulations of the locale and country where the study was conducted, and in compliance with Good Clinical Practice Guidelines. The rationale of the study, procedural details, and investigational goals were explained to each patient, along with potential risks and benefits. Each patient was assured of his\/her right to withdraw from the study at any time. Prior to the initiation of any study procedures, each patient signed and dated an approved ICF. The original was kept on file by the Investigator with the patient\u2019s records, and a copy was given to each patient.","order":5,"name":"Ethics","label":"Consent to Participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable; anonymized data.","order":6,"name":"Ethics","label":"Consent for Publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The datasets generated during and\/or analyzed during the current study were uploaded to\n                      \n                      .","order":7,"name":"Ethics","label":"Availability of Data and Material","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":8,"name":"Ethics","label":"Code Availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All authors critically revised the manuscript for intellectual content and approved the final version.","order":9,"name":"Ethics","label":"Authors\u2019 Contributions","group":{"name":"EthicsHeading","label":"Declarations"}}]}}