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William Lumry reports consultancy, speaking, and research support with AstraZeneca, BioCryst, CSL Behring, Kalvista, Ionis, Novartis, and Takeda; consultancy with Astria, Express Scripts\/CVS, Intellia, Pharvaris, and Novartis; and research support from Astria, Biomarin, Intellia, Kedrion, Lilly, Pharvaris, Teva, and Up Stream Bio.\u00a0Richard L. Wasserman reports Investigator for ADMA, GC Biopharma, Kedrion, and\u00a0Takeda; consultant for Evolve Biologicals, GC Biopharma, and Takeda; and\u00a0speaker for CSL Behring, Grifols, and Takeda.\u00a0Syed Rehman reports being speaker for AstraZeneca and Takeda; and research as Principal\u00a0Investigator with AstraZeneca, Sanofi, GSK, Pfizer, Evvomune, Celldex, Takeda, Chessi, Teva, and Winword.\u00a0Heather Lehman reports research as site Principal\u00a0Investigator with Sanofi, Novartis, and Chiesi.\u00a0Miranda Norton, Mirella Calcinai,\u00a0and\u00a0Aaron Kleyn are employees of Kedrion S.p.A. Elena Perez reports activities as Principal\u00a0Investigator, co-Principal\u00a0Investigator, or sub-investigator for clinical trials for Grifols, Kedrion, Green Cross, ADMA, Takeda, CSL Behring, Aimmune, ALK, Therapure Biopharma,\u00a0and Prometic; consultant and speaker (currently) for Grifols\u00a0and CSL Behring. Donald McNeil, Henry Kanarek, James Moy, Tina Zecca, and Jason Raasch have nothing to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"This study (NCT03961009; short title: CARES10, Clinical Assessment of phaRmacokinetics, Efficacy, and\u00a0Safety of 10% IVIg\u00a0in PID patients) was conducted in accordance with the accepted version of the Declaration of Helsinki in compliance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and according to the appropriate regulatory requirements in the countries where the study was conducted. All sites except Rush University Medical Center received ethical approval for the study by Copernicus Group Institutional Review Board, IRB number 20190538. For the site under Rush University Medical Center, ethical approval was provided from the Rush University Medical Center Institutional Review Board, IRB\u00a0number 19011803-IRB01. A data safety monitoring board, independent of the sponsor and investigators, was established for this study. The board periodically monitored, reviewed, and evaluated the safety and efficacy data, and reviewed specific adverse events to determine whether they met the criteria for acute serious bacterial infections. Signed informed consent was obtained from all subjects screened for inclusion in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}