Data Sharing Statement
Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participantre-identification. Submit requests to https://vivli.org/.
Acknowledgments
Medical writing/editorial assistance was provided by Claire Pickford, PhD, of Excerpta Medica, and was funded by Sanofi and Regeneron Pharmaceuticals Inc., according to the Good Publication Practice guidelines.
Disclosure
Lugogo NL reports clinical trial funding from Amgen, AstraZeneca, Avillion, Bellus Health, Evidera, Genentech, GSK, Gossamer Bio, Janssen, Novartis, Regeneron Pharmaceuticals Inc., Sanofi, and Teva; is or has been an advisory board member and consultant for Amgen, AstraZeneca, Avillion, Genentech, GSK, Novartis, Regeneron Pharmaceuticals Inc., Sanofi, and Teva; and is an honorable non-paid faculty member of the Observational and Pragmatic Research Institute (OPRI). Heffler E reports research grants from Almirall, AstraZeneca, Bosch, Boehringer Ingelheim, Circassia, Celltrion-Healthcare, Chiesi, GSK, Nestlé Purina, Novartis, Regeneron Pharmaceuticals Inc.Stallergenes-Greer, Sanofi, Teva, and Valeas. Plaza V reports clinical trial funding from AstraZeneca and Chiesi; is or has been an advisory board member and consultant for AstraZeneca, Boheringer-Ingelheim, Gebro, GSK, Menarini, Novartis, Sanofi, and Teva. Hilberg O is or has been an advisory board member for Sanofi. Xia C, Nash S, Deniz Y, and Soler X are employees and shareholders of Regeneron Pharmaceuticals Inc. Pandit-Abid N, Jacob-Nara JA, Rowe PJ, and Hardin M are employees of Sanofi and may hold stock and/or stock options in the company. Sacks H is an employee of Regeneron Pharmaceuticals Inc., and a shareholder of Optinose. The authors report no other conflicts of interest in this work.