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Article History

Received: 24 October 2020

Accepted: 5 January 2021

First Online: 29 January 2021

Ethics approval and consent to participate

: HATRIC was approved by the Health Research Authority (17/SC/0653 HATRIC; IRAS Project ID: 230883; Sponsor’s Ref Number: 24375). HATRIC-Q was also approved by the HRA (HRA REC: 18/NE/0016; IRAS Project ID: 233467; University of Southampton REC number 29921). On advice from the UK Medicines and Healthcare products Regulatory Agency (MHRA), this feasibility study is not classed as a Clinical Trial of an Investigational Medicinal Product (CTIMP) because the outcome measures do not include efficacy of the product and so a clinical trial authorisation (CTA) is not required for this feasibility trial. The sponsor of the trial was the University of Southampton with the coordination of the trial undertaken by the UK Clinical Research Collaboration registered Southampton Clinical Trials Unit (a NIHR CTU support funded Clinical Trials Unit). Participants in the HATRIC trial provided written consent. Those who took part in the qualitative interviews also provided verbal consent, because the interviews were conducted by telephone. This was approved by the ethics committee.

: Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany provided the IMP free of charge and provided payment for access to the anonymised aggregated data at the end of the trial. The study was run independently and the company was not involved in analysing the data. They reviewed the article but did not have editorial rights.