We thank Dr. Jan Kiszko for his contributions to earlier versions of this work. We thank all THAOS patients and investigators for their important contributions to this study.
Additional THAOS investigators contributing to this analysis: Fabio Barroso, FLENI, Ciudad Autonoma de Buenos Aires, Argentina; Johan van Cleemput, Afdeling Klinische Cardiologie, O&N I, Leuven, Belgium; Hartmut Schmidt, Universitätsklinikum Münster – Transplant Hepatology, Münster, Germany; Burkhard Gess, University Hospital of RWTH Aachen, Aachen, Germany; Pablo Garcia Pavia, Hospital Universitario Puerta de Hierro, Majadahonda, Spain; José Luis Muñoz Blanco, Hospital Gregorio Marañón, Madrid, Spain; Claudio Rapezzi, Comitato Etico Indipendente dell Azienda, Bologna, Italy; Giuseppe Vita, AOU Policlinico G. Martino, Messina, Italy; Giampaolo Merlini, Centro per lo Studio e la Cura delle Amiloidosi Sistemiche, Pavia, Italy; Marco Luigetti, Fondazione Policlinico Gemelli – Universita Cattolica del Sacro Cuore, Roma, Italy; Yesim Parman, Istanbul University, Istanbul Faculty of Medicine, Department of Neurology, Istanbul, Turkey; Mathew Maurer, Columbia University Medical Center, New York, NY, USA; Samantha LoRusso, The Ohio State University College of Medicine, Columbus, OH, USA.
The THAOS registry and this analysis were sponsored by Pfizer. Medical writing support was provided by Caitlin Watson, PhD, of Engage Scientific Solutions, and funded by Pfizer, who also provided funding for the journal’s Rapid Service Fee.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
All authors contributed to the design and conduct of the analysis; interpretation of the data; and preparation, review, and approval of the manuscript.
Luca Gentile reports travel grants from Kedrion and CSL Behring to attend scientific meetings. Ivailo Tournev reports sponsorship from Pfizer for participation in advisory boards, congresses, and conferences. Leslie Amass is a full-time employee of Pfizer and holds stock and/or stock options with Pfizer. Doug Chapman is a full-time employee of Pfizer and holds stock and/or stock options with Pfizer. Anna Mazzeo reports travel grants from Kedrion and CSL Behring to attend scientific meetings.
Compliance with Ethics Guidelines
All THAOS study sites received ethical or institutional review board approval prior to patient enrollment, and each patient provided written informed consent. The study followed the International Council for Harmonisation Good Pharmacoepidemiology Practice guidelines and the principles of the Declaration of Helsinki.
Pfizer provides secure access to anonymized patient-level data to qualified researchers in response to scientifically valid research proposals. Further details can be found at https://www.pfizer.com/science/clinical-trials/trial-data-and-results.