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Article History

Received: 19 April 2023

Accepted: 11 December 2023

First Online: 18 January 2024

Declarations

:

: This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. The protocol, Informed Consent Form, and other relevant documents were submitted to an Institutional Review Board/Independent Ethics Committee (IRB/IEC) by the investigator and reviewed and approved by the IRB/IEC before the study was initiated.

: Participants or their legally acceptable representatives provided their written consent to participate in the study after having been informed about the nature and purpose of the study and participation/termination conditions. Informed consent was obtained before enrollment into the study on the first visit. Personal data from participants enrolled in this study (limited to those data necessary to address the objectives of the study) were collected and processed with adequate precautions to ensure confidentiality and compliance with applicable data privacy protection laws and regulations. A copy of the ICF(s) was provided to the participant or the participant’s legally authorized representative.

: Joachim Doua is an employee of Janssen Research & Development (a pharmaceutical company of Johnson & Johnson). Miquel Ekkelenkamp discloses that this project was funded by Innovative Medicines Initiative (IMI) of European Commission (hours declared on this project), COMBACTE-NET (grant agreement number 115523). Theo Verheij has no conflicts of interest to disclose. Oscar Go is an employee of Janssen Research & Development and owns equities. Stephen Ruhmel is an employee of Janssen Research & Development and owns stock and options in Johnson & Johnson. Kimberly Leathers has no conflicts of interest to disclose. Bart Spiessens was an employee of Janssen (a pharmaceutical company of Johnson & Johnson) at the time of the study and owns shares in Janssen. Sanne van Rooij has no conflicts of interest to disclose. Vance G. Fowler Jr discloses support for the present manuscript from the NIH; grants or contracts to his affiliated institution from the NIH, MedImmune, Allergan, Pfizer, Advanced Liquid Logics, Theravance, Novartis, Merck, Medical Biosurfaces, Locus, Affinergy, Contrafect, Karius, Genentech, Regeneron, Basilea, Janssen; royalties and licences from UpToDate; consulting fees from Novartis, Debiopharm, Genentech, Achaogen, Affinium, Medicines Co., MedImmune, Bayer, Basilea, Affinergy, Janssen, Contrafect, Regeneron, Destiny, Amphliphi Biosciences, Integrated Biotherapeutics, C3J, Armata, Valanbio, Akagera, Aridis, Roche, Pfizer; support by Contrafect for presenting phase 2 data at ECCMID 2019; a sepsis diagnostics patent; a role as an associate editor for <i>Clinical Infectious Diseases</i> between 2017–2022; and stock/stock options in ArcBio and ValanBio. Jeroen Geurtsen is an employee of Janssen Vaccines & Prevention (a pharmaceutical company of Johnson & Johnson) and owns stock options in Johnson & Johnson. Rowena Dolor discloses payments made to Duke University for this research project and a relationship with Universitair Medisch Centrum Utrecht. Michal Sarnecki is an employee of Janssen Vaccines, Branch of Cilag GmbH International Pharmaceutical (a pharmaceutical company of Johnson & Johnson) and owns unrestricted shares in Janssen Vaccines. Ranee Chatterjee has no conflicts of interest to disclose. Jan Poolman is an employee of Janssen Research & Development and owns stock options in Janssen Research & Development. Marc Bonten discloses grants or contracts paid to the University Medical Centre Utrecht (UMCU) by Janssen Vaccines, Novartis, CureVac and Merck; payment or honoraria to MJMB from Takeda; and payments to UMCU for participation on a data safety monitoring board or advisory board from Sanofi, Spherecydes, Pfizer, Merck, Novartis, and AstraZeneca.