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Jan-Stefan van der Walt, Julia Winkler, and Rik Schoemaker are full-time employees of Occams Co\u00f6peratie UA, Amstelveen, the Netherlands. At the time the study was conducted, Jan-Stefan van der Walt was a full-time employee of Eli Lilly and Company, Indianapolis, IN, USA, and was a minority holder of company stock.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All studies included in this analysis were approved by appropriate ethics committees and were conducted in accordance with the principles of the Declaration of Helsinki and the International Council on Harmonisation Good Clinical Practice guidelines.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Written informed consent was obtained from all participants of the studies included in this analysis.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Eli Lilly and Company provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the USA and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at .","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"J.-S.v.d.W. conceived and designed the study. J.B. was responsible for scientific oversight of immunogenicity and biomarker sample analysis. D.E.J., J.W., and R.S. analyzed the data. D.E.J., J.-S.v.d.W., J.B., J.W., and R.S. interpreted the data. D.E.J., J.B., and J.-S.v.d.W. drafted the manuscript. J.W. and R.S. critically revised the manuscript for important intellectual content. All authors read and approved the final version of the manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}