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Haukeland University Hospital, Bergen, Norway (Ø.F., I.G.R., K.S., J.A., I.K., O.B., K.R., K.A.)
University Hospital of Oslo, Oslo, Norway (K.L., I.H., S.S.M.)
Notodden Hospital, Notodden, Norway (H.T., A.E.L.)
St. Olavs Hospital, Trondheim, Norway (BC, M.E.G., Ø.K., K.A.B., A.H.S.)
University Hospital of Northern Norway, Tromsø, Norway (C.S., L.M.B., A.E.G.)
Haukeland University Hospital and University of Bergen, Bergen, Norway (O.D., O.M.)
Note: All authors had authority over the preparation of the manuscript and the decision to submit it for publication. The manuscript is an accurate record of the study and no important aspect of the essay has been omitted.
Recognition: The authors thank the Safety Oversight Committee for the test (Professor Ola D. Saugstad and Associate Professor Unn M. Fagerli) and the following staff for testing centers for technical assistance and scientific: Helle Øvrebø, RN, OCN; Anne L. Falch, RN, OCN; and Tor H. Wiestad, MSc, Haukeland University Hospital; Bente Bråthen Berg, RN; Semhar Abraham; and Liv Sæter Sjue, RN, at the University Hospital of Oslo; Thomas Fufa Baisa, MD, at Notodden Hospital; Hilde A. Abrahamsen, RN; Siv B. Rogstad, RN; and Vegard Strøm, RN, at St. Olavs Hospital; and Tom Sollid, CLS, at the University Hospital of Northern Norway.
Financial aid: The RituxME trial received funding from the Norwegian Research Council, the Norwegian Regional Health Funds, the MEandYou Foundation, the Norwegian ME Association and the Torstein Hereid legacy. The ME / CFS Research Group at Haukeland University Hospital receives funding from the Kavli Trust.
Disclosures: Dr. Fluge reports grants for the study of the Norwegian Research Council, the Norwegian Regional Health Funds, the Kavli Trust, the MEandYou Foundation and the Norwegian Association ME in carrying out the study. In addition, Haukeland University Hospital holds patents and patent applications on the issue of B-cell depletion treatment of chronic fatigue syndrome (ME / CFS). Dr. Fluge is mentioned as an inventor in these applications. Dr. Rekeland reports subsidies from Norwegian regional health trusts during the study. Dr. Lien reports grants awarded by Norwegian regional health trusts during the course of the study. Dr. Schäfer mentions subsidies granted by Norwegian regional health trusts during the course of the study. Ms Sørland reports subsidies from Norwegian regional health trusts and non-financial support from NorCRIN (Norwegian Network of Clinical Research Infrastructure) during the study. Dr Ktoridou-Valen mentions grants awarded by Norwegian Regional Health Trust Funds during the study. Dr. Herder reports subsidies granted by Norwegian regional health trusts during the course of the study. Dr. Baranowska reports grants from Norwegian regional health trusts during the study. Dr. Bohnen announced grants from Norwegian regional health trusts during the study. Ms Martinsen reports grants from Norwegian regional trust funds for the conduct of the study. Lonar reports grants from Norwegian regional health trusts during the study. Ms Solvang reports grants from Norwegian regional health trusts during the study. Mr Gya reports subsidies granted by Norwegian regional health trusts during the study. Risa reports grants from the Kavli Trust during the study. Ms. Alme reports grants from the Kavli Trust during the course of the study. Dr. Mella announced grants for the study of the Norwegian Research Council, the Norwegian Regional Health Trusts, the Kavli Trust, the MEandYou Foundation and the Norwegian ME Association during the study. In addition, Haukeland University Hospital holds patents and patent applications on the issue of B-cell depletion treatment of chronic fatigue syndrome (ME / CFS). Dr. Mella is mentioned as an inventor in these applications. The unnamed authors here have revealed no conflict of interest. Disclosures can also be found at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-1451.
Disclosures of the editors: Christine Laine, MD, MPH, editor-in-chief, says his wife holds stock / asset purchase options with targeted diagnoses and therapies. Darren B. Taichman, MD, PhD, editor, says that he has no financial relationship and no interest in disclosing. Cynthia D. Mulrow, MD, MSc, Associate Editor, says she has no relationship or interest in disclosing. Jaya K. Rao, MD, MHS, Associate Editor, says she has stock / options to buy in Eli Lilly and Pfizer. Catharine B. Stack, PhD, MS, Associate Editor of Statistics, says she owns shares in Pfizer, Johnson & Johnson and Colgate-Palmolive. Christina C. Wee, MD, MPH, Associate Editor, reports a job at Beth Israel Deaconess Medical Center. Sankey V. Williams, MD, deputy editor, says that he has no financial relationship and no interest in disclosing. Yu-Xiao Yang, MD, MSCE, deputy editor, says that he has no financial relationship nor any interest in disclosing.
Repeatable Research Statement:Study protocol: See Supplement 1. Statistical code: Examples of analysis codes can be found in the Methods section of the appendage. Dataset: Available for approved individuals through written agreements with the author and the research sponsor.
Corresponding author: Øystein Fluge, MD, PhD, Department of Oncology and Medical Physics, Haukeland University Hospital, Jonas Lies vei 65, N-5021 Bergen, Norway; e-mail, [email protected].
Address of the current author: Drs. Fluge, Rekeland and Ktoridou-Valen; Mrs Sørland; Mrs. Risa; Ms. Alme; and teachers. Dahl and Mella: Department of Oncology and Medical Physics, Haukeland University Hospital, Jonas Lies vei 51, N-5021 Bergen, Norway.
Dr. Lien and Mrs. Martinsen: CFS / ME Center, Division of Medicine, Aker Hospital, Oslo University Hospital, PO Box 4959 Nydalen, N-0424 Oslo, Norway.
Dr Thürmer and Mrs Lonar: Telemark Hospital, Department of Medicine, Notodden Hospital, Henrik Wergelands gt. 9, N-3675 Notodden, Norway.
Professor Borchgrevink; Drs. Gotaas, Kvammen and Baranowska; and Ms. Solvang: Department of Pain and Complex Disorders, St. Olavs Hospital, PO Box 3250 Sluppen, N-7006 Trondheim, Norway.
Drs. Schäfer and Bohnen and M. Gya: Division of Rehabilitation Services, University Hospital of Northern Norway, PO Box 1, N-9038 Tromsø, Norway.
Dr. Aßmus: Department of Research and Development, Haukeland University Hospital, Jonas Lies vei 51, N-5021 Bergen, Norway.
Dr. Herder: Section of Climate Therapies, University Hospital of Oslo, Rikshospitalet, PO Box 4950 Nydalen, N-0424 Oslo, Norway.
Dr. Bruland: Department of Medical Genetics and Molecular Medicine, Haukeland University Hospital, Jonas Lies vei 51, N-5021 Bergen, Norway.
Author contributions: Design and design: Ø. Fluge, O. Mella.
Analysis and interpretation of the data: Ø. Fluge, I. G. Rekeland, K. Sørland, J. Aussus, O. Mella.
Article writing: Ø. Fluge, I. G. Rekeland, K. Sørland, J. Aussus, O. Mella.
Critical review of the article for important intellectual content: Ø. Fluge, I. G. Rekeland, K. Sørland, J. Aussus, K. Alme, O. Dahl, O. Mella.
Final approval of the article: Ø. Fluge, I.G. Rekeland, K. Link, H. Thürmer, P.C. Borchgrevink, C. Schäfer, K. Sørland, J. Aussus, I. Ktoridou-Valen, I. Herder, E. E. Gotaas, Ø. Kvammen, K.A. Baranowska, L.M.L.J. Bohnen, S.S. Martinsen, A.E. Lonar, A.H. Solvang, A.E.S. Gya, O. Bruland, K. Risa, K. Alme, O. Dahl, O. Mella.
Supply of study materials or patients: Ø. Fluge, I.G. Rekeland, K. Link, H. Thürmer, P. C. Borchgrevink, C. Schäfer, K. Sørland, I. Ktoridou-Valen, I. Herder, M. E. Gotaas, Ø. Kvammen, K.A. Baranowska, L.M.L.J. Bohnen, S.S. Martinsen, A.E. Lonar, A.H. Solvang, A.E.S. Gya, O. Mella.
Statistical expertise: J. Aßmus.
Obtaining funding: Ø. Fluge, O. Mella.
Administrative, technical or logistical support: K. Sørland, S.S. Martinsen, A.E. Lonar, A.H. Solvang, A.E.S. Gya, O. Bruland, K. Risa, K. Alme, O. Dahl, O. Mella.
Collection and assembly of data: Ø. Fluge, I.G. Rekeland, K. Link, H. Thürmer, C. Schafer, K. Sørland, I. Herder, E. E. Gotaas, Ø. Kvammen, K.A. Baranowska, L.M.L.J. Bohnen, S.S. Martinsen, A.E. Lonar, A.H. Solvang, A.E.S. Gya, O. Mella.
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