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Epub 1993\/12\/30.","journal-title":"Stat Med"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-017-2406-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s13063-017-2406-5\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-017-2406-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,8,12]],"date-time":"2022-08-12T20:39:47Z","timestamp":1660336787000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-017-2406-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,1,18]]},"references-count":52,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2018,12]]}},"alternative-id":["2406"],"URL":"https:\/\/doi.org\/10.1186\/s13063-017-2406-5","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,1,18]]},"assertion":[{"value":"8 June 2017","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 December 2017","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 January 2018","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The institutional review board of the Johns Hopkins Bloomberg School of Public Health reviewed and approved the initial protocol on 9 July 2015, IRB nmber 00006303. Individual clinical centers received approval from their respective IRBs as follows: University of Arkansas, 7 April 2015, protocol 203507; Central Arkansas Veterans Healthcare System institutional review board, 17 August 2015, protocol 639677-3; Western Institutional Review Board, 16 August 2015, protocol 20150480; University Hospitals Case Medical Center institutional review board, 26 May 2015, protocol 05-15-11; Emory University institutional review board, 28 May 2015, IRB00080186; Johns Hopkins Medicine institutional review board, 6 April 2015; IRB00064958; University of Rochester institutional review board, 23 August 2015, RSRB 56395; Roper St. Francis institutional review board, 06 May 2015, protocol 736159-1; Sunnybrook Health Sciences Centre research ethics board, 24 September 2015, 505-2014; Wake Forest University Health Sciences institutional review board, 1 May 2015, IRB 31928; Yale university institutional review board, 10 June 2015, protocol 1503015481. These institutional review boards approved all subsequent amendments to the ADMET 2 protocol. ADMET 2 is being conducted in accordance with the Declaration of Helsinki. Informed consent from both the study participant and his or her caregiver is required prior to study entry and administration of any intervention. Copies of the informed consent template are attached as an appendix.","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":"The authors declare that they have no 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":"46"}}