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Authors
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Hartshorn, Stuart https://orcid.org/0000-0003-0419-1564
Barrett, Michael J.
Lyttle, Mark D.
Yee, Sue Anne
Irvine, Alan T.
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Funding
Funding for this research was provided by:
Medical Developments International Limited
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Article History
Received: 19 February 2019
Accepted: 10 June 2019
First Online: 4 July 2019
Ethics approval and consent to participate
: The protocol, PIS, consent form and all relevant documentation for this clinical trial were approved for the UK by the South Central (Oxford A) Research Ethics Committee (17/SC/0039) and, in a separate process, for Ireland by Our Lady’s Children’s Hospital, Crumlin (GEN/539/17). All participating centres confirm capacity prior to commencing recruitment.For patients under the age of 16 years, written informed consent is sought from the patient’s parent or legal guardian, together with verbal assent from the patient. Competent 16 and 17 year olds provide their own written consent. Given the short timeframe for recruiting patients in EDs, a summary PIS is used. Parents have the opportunity to read this and are given the full PIS to take home. This approach was approved by the ethic committees.
: Not applicable.
: The authors declare that they have no competing interests.
