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Data are available to request 6 months after the indication studied has been approved in the US and European Union 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, 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\n                      \n                      .","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of Data and Material"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code Availability"}},{"value":"SS: conceptualization, methodology, writing (review and editing), project administration, funding acquisition; CK: conceptualization, methodology, writing (review and editing); OJV: writing (review and editing), project administration; JB: conceptualization, methodology, writing (review and editing); EBD: writing (review and editing); CD-B: conceptualization, methodology, validation, formal analysis, investigation, resources, data curation, writing (original draft), writing (review and editing), visualization, supervision, project administration, funding acquisition; NT: conceptualization, methodology, validation, formal analysis, investigation, resources, data curation, writing (review and editing), supervision, project administration, funding acquisition.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 Contributions"}}]}}