Lessening Organ Dysfunction With Vitamin C (LOVIT) Trial: Statistical Analysis Plan

Neill KJ Adhikari   ^{1, 2 *} , MDCM, MSc ;   Ruxandra Pinto   ¹ , PhD ;   Andrew G Day   ^{3, 4} , MSc ;   Marie-Hélène Masse   ⁵ , MSc ;   Julie Ménard   ⁵ , PhD ;   Sheila Sprague   ⁶ , PhD ;   Djillali Annane   ^{7, 8, 9} , MD, PhD ;   Yaseen M Arabi   ^{10, 11, 12} , MD ;   Marie-Claude Battista   ¹³ , PhD ;   Dian Cohen   ^{14, 15} , CM, OM ;   Deborah J Cook   ^{16, 17, 18} , MD, MSc ;   Gordon H Guyatt   ¹⁸ , MD, MSc ;   Daren K Heyland   ^{19, 20, 21} , MD, MSc ;   Salmaan Kanji   ^{22, 23} , BPharm, PharmD ;   Shay P McGuinness   ^{24, 25, 26} , MBChB ;   Rachael L Parke   ^{24, 25, 26, 27} , MHSc, PhD ;   Bharath Kumar Tirupakuzhi Vijayaraghavan   ^{28, 29} , MD ;   Emmanuel Charbonney   ^{30, 31} , MD, PhD ;   Michaël Chassé   ^{30, 32} , MD, PhD ;   Lorenzo Del Sorbo   ^{2, 33} , MD ;   Demetrios James Kutsogiannis   ³⁴ , MD, MHS ;   François Lauzier   ^{35, 36, 37, 38} , MD, MSc ;   Rémi Leblanc   ^{39, 40} , MD ;   David M Maslove   ^{3, 19, 41} , MD, MSc ;   Sangeeta Mehta   ^{2, 42} , MD ;   Armand Mekontso Dessap   ^{43, 44, 45} , MD, PhD ;   Tina S Mele   ⁴⁶ , MD, PhD ;   Bram Rochwerg   ^{16, 18} , MD, MSc ;   Oleksa G Rewa   ³⁴ , MD, MSc ;   Jason Shahin   ^{47, 48} , MD, MSc ;   Pawel Twardowski   ⁴⁹ , MD, PhD ;   Paul Jeffrey Young   ^{25, 26, 50} , MD, PhD ;   François Lamontagne   ^{5, 13 *} , MD, MSc ;   LOVIT Investigators   ⁵¹

¹ Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada

² Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada

³ Kingston Health Sciences Centre, Kingston, ON, Canada

⁴ Department of Public Health Sciences, Queen's University, Kingston, ON, Canada

⁵ Research Centre of the Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada

⁶ Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada

⁷ Department of Intensive Care Medicine, Raymond-Poincaré Hospital (Assistance Publique - Hôpitaux de Paris [AP-HP]), Garches, France

⁸ Institut National de la Santé et de la Recherche Médicale, Université Paris-Saclay Campus Université de Versailles Saint-Quentin-en-Yvelines, Versailles, France

⁹ Fédération Hospitalo-Universitaire SEPSIS, Garches, France

¹⁰ College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia

¹¹ King Abdullah International Medical Research Center, Riyadh, Saudi Arabia

¹² Department of Intensive Care, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia

¹³ Department of Medicine, Université de Sherbrooke, Sherbrooke, QC, Canada

¹⁴ Bishop's University, Sherbroooke, QC, Canada

¹⁵ Massawippi Valley Foundation, Ayer's Cliff, QC, Canada

¹⁶ Department of Medicine, McMaster University, Hamilton, ON, Canada

¹⁷ Department of Critical Care, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada

¹⁸ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada

¹⁹ Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada

²⁰ Kingston General Health Research Institute, Kingston Health Sciences Centre, Kingston, ON, Canada

²¹ Clinical Evaluation Research Unit, Kingston General Hospital, Kingston, ON, Canada

²² The Ottawa Hospital Research Institute, Ottawa, ON, Canada

²³ Department of Pharmacy, The Ottawa Hospital, Ottawa, ON, Canada

²⁴ Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand

²⁵ Medical Research Institute of New Zealand, Newtown, New Zealand

²⁶ Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia

²⁷ School of Nursing, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand

²⁸ Department of Critical Care Medicine, Apollo Hospitals, Chennai, India

²⁹ The George Institute for Global Health, New Delhi, India

³⁰ Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada

³¹ Centre de Recherche de l'Hôpital du Sacré-Coeur de Montréal, Montréal, QC, Canada

³² Department of Medicine, Université de Montréal, Montréal, QC, Canada

³³ Department of Medicine, University Health Network, Toronto, ON, Canada

³⁴ Department of Critical Care Medicine, University of Alberta, Edmonton, AB, Canada

³⁵ Department of Medicine, Université Laval, Québec, QC, Canada

³⁶ Department of Anesthesiology and Critical Care, Université Laval, Québec, QC, Canada

³⁷ Population Health and Optimal Health Practices Research Unit, Traumatology - Emergency - Critical Care Medicine, Centre Hospitalier Universitaire de Québec - Université Laval Research Center, Centre Hospitalier Universitaire de Québec - Université Laval, Québec, QC, Canada

³⁸ Critical Care Medicine Service, Centre Hospitalier Universitaire de Québec - Université Laval, Quebec, QC, Canada

³⁹ Department of Medicine, Centre Hospitalier Universitaire Dr Georges-L. Dumont, Moncton, NB, Canada

⁴⁰ Division of Intensive Care, Centre Hospitalier Universitaire Dr Georges-L. Dumont, Moncton, NB, Canada

⁴¹ Department of Medicine, Queen's University, Kingston, ON, Canada

⁴² Sinai Health System, Toronto, ON, Canada

⁴³ Service de Médecine Intensive Réanimation, Assistance Publique - Hôpitaux de Paris [AP-HP], Hôpitaux Universitaires Henri-Mondor, Créteil, France

⁴⁴ Groupe de Recherche Clinique CARMAS (Cardiovascular and Respiratory Manifestations of Acute lung injury and Sepsis), Université de Paris Est Créteil, Créteil, France

⁴⁵ Institut Mondor de Recherche Biomédicale, Institut National de la Santé et de la Recherche Médicale, Université Paris Est Créteil, Créteil, France

⁴⁶ Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada

⁴⁷ Department of Medicine, McGill University Health Centre, Montréal, QC, Canada

⁴⁸ Department of Critical Care, McGill University Health Centre, Montréal, QC, Canada

⁴⁹ Department of Surgical Sciences, University of Otago, Dunedin, New Zealand

⁵⁰ Intensive Care Unit, Wellington Hospital, Newton, New Zealand

⁵¹ See Acknowledgements

*these authors contributed equally