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JAMA Surg. 2017;152:224\u201332.","journal-title":"JAMA Surg"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-019-3244-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s13063-019-3244-4\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-019-3244-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,14]],"date-time":"2023-09-14T04:18:11Z","timestamp":1694665091000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-019-3244-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,3,4]]},"references-count":51,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,12]]}},"alternative-id":["3244"],"URL":"https:\/\/doi.org\/10.1186\/s13063-019-3244-4","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,3,4]]},"assertion":[{"value":"20 March 2018","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 February 2019","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 March 2019","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Approval for the study has been obtained from the ethics committee responsible for the sponsor and from the responsible German federal agency (the <i>Paul-Ehrlich-Institut<\/i>) and from local ethics committees as appropriate. No invasive study procedure will be commenced if written informed consent to participate in the trial has not been obtained from the subject, a legal representative, a court-appointed carer or a study-independent consultant physician. A list of the ethics committees involved can be made available on request.Important protocol modifications will be made public on clinicaltrials.gov.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"AB and UG are employees of Biotest AG, manufacturer of Pentaglobin\u00ae (IgGAM). CK is an employee of the RWTH Aachen University. KZ has received various research stipends, honoraria and lecturer\u2019s fees, including from Biotest AG. There are no other actual or potential competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Publisher\u2019s Note"}}],"article-number":"156"}}