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Article History

Received: 6 January 2020

Accepted: 31 August 2020

First Online: 15 October 2020

Ethics approval and consent to participate

: All subjects and/or their guardians gave written informed consent to participate in the study. The study was approved by the Mount Sinai Hospital Research Ethics Board (Toronto – Managing center) and local centers (07–0322-E). The local centers are comprised of: the Conjoint Health Research Ethics Board (Calgary), The Research Ethics Office (Edmonton), the Nova Scotia Health Authority (Halifax), the Hamilton Integrated Research Ethics Board (Hamilton), the Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (Kingston), Western’s Research Ethics Boards (London, ON), the Research Centre of the Sainte-Justine University Hospital Research Ethics Board (Ste-Justine), McGill Research Ethics Boards (McGill), the Office of Research Ethics and Integrity (Ottawa), the Interdisciplinary Committee on Ethics in Human Research (St John’s), the Clinical Research Ethics and Regulatory Compliance Office (Sick Kids Hospital), the UBC Office of Research Ethics (Vancouver), the Biomedical Research Ethics Board (Winnipeg), the comité d’éthique de la recherche (Hôpital du St-Sacrement), the University of Saskatchewan Research Ethics Board (Saskatoon), the Sunnybrook’s research ethics board (Sunnybrook), the MUHC Centre for Applied Ethics (Hôpital Maisonneuve-Rosemont), the UBC Providence Health Care Research Ethics Board (Rhode Island), the University Health Network Research Ethics Board (Toronto General Hospital), Comité d’éthique de la recherche du CIUSSS de l’Estrie (Sherbrooke), the Institutional Review Board (Connecticut), The DHMC Clinical Ethics Committee (Dartmouth-Hitchcock Medical Center), the Helsinki Committee (Shaare Zedek), the Helsinki Committee of Rambam (Rambam), the Tel Aviv Sourasky Medical Center Institutional Review Board (Tel Aviv Sourasky Medical Center), the Helsinki Committee of Soroka (Soroka Medical Center), the Helsinki Committee of Baruch Padeh Medical Center, Poria (Poria Medical Center), Kaplan Medical Center Helsinki Committee, the Kaplan Medical Center, Rehovot (Kaplan), the Helsinki Committee of Tel Hashomer (Tel Hashomer Hospital), the Helsinki Committee of Emek (Emek), the Assaf Harofeh Medical Center Helsinki Committee, Assaf Harofeh Medical Center, Zerifin (Asaf Harofe), the Institutional Review Board (Boston), the Ethics Center at Cincinnati Children’s (Cincinnati), the UNC Office of Human Research Ethics (North Carolina), the UMOR Ethics & Compliance (Michigan), the Research Ethics Board (Winnipeg - John Buhler Research Centre), the Helsinki Committee of Barzilai (Barzilai Medical Center), the Helsinki Committee (Beilinson\Schneider), the Helsinki Committee of Maccabi (Maccabi Hashalom), the Helsinki Committee of Wolfson (Wolfson), the BSD/UCMC Institutional Review Boards at the University of Chicago (Chicago), the Miami Research Ethics and Integrity Program (Miami), the Lady’s Children’s Hospital Crumlin Research Ethics Committee (Ireland), the Hospital Research Ethics Committee (Ireland), the West of Scotland Research Ethics Committee 4 (Royal Hospital for Sick Children - Edinburgh), the Convener of the University Research Ethics Committee (Ninewells - Dundee), the West of Scotland Research Ethics Committee 4 (Western General Hospital - Edinburgh), the West of Scotland Research Ethics Committee 4 (Yorkhill - Glasgow), the West of Scotland Research Ethics Committee 4 (The Glasgow Royal Infirmary), the NRES Research Ethics Committee (Aberdeen Royal Infirmary the West of Scotland Research Ethics Committee 4 (Raigmore Hospital), the NHS Research Ethics Committee (The Hull University Teaching Hospitals), the Interior Health Research Ethics Board (The Royal Liverpool University Hospital), the South Birmingham Local Research Ethics Committee (Queen Elizabeth Hospital Birmingham), the HRA National Research Ethics Service (Birmingham Children’s Hospital), the University Hospitals of Coventry and Warwickshire Clinical Ethics Committee (University Hospital Coventry), the North West - Greater Manchester Central Research Ethics Committee (Queen’s Medical Centre), the Royal Devon and Exeter NHS Foundation Trust (The Royal Devon and Exeter Hospital), the Southampton & South West Hampshire local research ethics committee (Southampton General Hospital), the Central University Research Ethics Committee (The John Radcliffe Hospital), the National Research Ethics Service (Addenbrooke’s Hospital), the NHS Research Ethics Committee (Norfolk and Norwich University Hospitals), the Clinical Ethics Committee at Barts and the London NHS Trust (St Bartholomew’s Hospital), the West of Scotland Research Ethics Committee 4 (University Hospital Crosshouse), the Great Ormond Street Clinical Ethics Service (Great Ormond Street Hospital), t NHS Lothian (Alder Hey Children’s Hospital), the West of Scotland Research Ethics Committee 4 (Forth Valley Royal Hospital), the Human Research Protection Office (CHIP Pittsburgh), North West - Greater Manchester East Research Ethics Committee (Salford royal hospital), the Memorial Health Services Research Council (MemorialCare’s Long Beach Medical Center), the Bnai-Zion Medical Center Helsinki Committee (Bnai Zion Medecal Center), the Institutional Review Board (Children’s Hospital Los Angeles), the West of Scotland Research Ethics Committee 4 (Gartnavel General Hospital), the Southern District Health Board and the Dunedin School of Medicine (Dunedin Hospital), the Central University Research Ethics Committee (John Radcliffe Hospital), the Code of Ethics and Corporate Compliance Program of Atlantic Health System (New Jersey), the University Ethics of Research Committee (University Hospitals Bristol), the UC Irvine Interdisciplinary Center for the Scientific Study of Ethics and Morality (University of California Irvine), the NHS Research Ethics Committees (Royal Free Hospital), the Wirral University Teaching Hospital NHS (Arrowe Park Hospital), the Tallaght University Hospital / St. James’s Hospital Joint Research Ethics Committee (St James’s Hospital), the Auckland Health Research Ethics Committee (Auckland District Health Board), the Waikato DHB (Waikato District Health Board), the Helsinki Committee (Emek Medical Center), the Institutional Review Board (Children’s Hospital of Philadelphia), the Helsinki Committee (Karmel Medical Centre), the NHS Research Ethics Committees (Barnet and Chase Farm NHS Hospitals), the NHS Research Ethics Committees (New Victoria Hospital), the QIMR Berghofer Medical Research Institute-Human Research Ethics Committee (QIMR Berghofer Medical Research Institute), the Helsinki Committee (French Hospital Nazereth), the Regional Ethics Review Board in Stockholm (Örebro University Hospital), the Regional Ethics Review Board in Stockholm (Karolinska University Hospital), and Regional Ethics Review Board in Stockholm (Linköping University Hospital).

: Not applicable.

: All authors disclose no potential conflicts (financial, professional, or personal) that are relevant to the manuscript.