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Authors
Lau, Tin Man Mandy https://orcid.org/0000-0001-5894-570X
Lowe, John
Pickles, Timothy
Hood, Kerenza
Kotecha, Sailesh
Gillespie, David
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Funding
Funding for this research was provided by:
Health Technology Assessment Programme (16/111/106)
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Article History
Received: 8 March 2022
Accepted: 29 July 2022
First Online: 23 August 2022
Declarations
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: The current version of the AZTEC protocol is 3.0, dated 20/06/2019. Ethics permission has granted by the Wales Research Ethics Committee 2 (Ref 18/WA/0199) and regulatory permission by the Medicines and Healthcare Products Regulatory Agency (CTA reference 21323/0050/001–0001). NHS permission has been granted by the Health Research Authority and capacity and capability confirmed by each individual NHS organisation. The study is registered on EudraCT (2018–001109-99), ISRCTN (ISRCTN11650227), and on the National Institute for Health Research portfolio (CPMS 39385). Cardiff University is the Sponsor.Oversight of the study is being performed by an independent Data Monitoring Committee and an independent Trial Steering Committee. Appointments to these committees were made with approval of the NIHR HTA.
: Parental input was obtained during the grant application on the design and conduct of the study. Parent representatives also reviewed public-facing information (e.g., information sheets and consent forms) and are members of the Trial Management Group.
: The authors declare that they have no competing interests.
