Funding for this research was provided by:
Homeopathy Research Institute (?)
Received: 11 May 2017
Accepted: 2 February 2018
First Online: 2 March 2018
Ethics approval and consent to participate
: The study was approved under the University of Sheffield’s Ethics Review Procedure by the School of Health and Related Research (ScHARR) Research Ethics committee (REC) on 30/4/15, application number 003424.The University of Sheffield is the Research Governance Sponsor (University Research Management System (UMRS) number: 143647). The project was classified as a ‘human-interventional study’, under the University’s quality assurance procedure for such studies, requiring it to be risk assessed, and was considered to be low risk. They confirmed that a trial measuring treatment by a homoeopath and a nutritionist did not constitute a Clinical Trial of a Medicinal Product (CTIMP); therefore, Medicines Regulatory Health Authority (MRHA) approval was not required.The study was registered with the ISRCTN Registry (International Standard Randomised Controlled Trials Number 17723526) on 27/4/2015.The study is overseen by an independent Steering Committee of academics, clinicians and patient representatives, who meet every 6 months for the duration of the trial.
: All data are anonymised. Schools and participants are informed that their data will be anonymised and kept in a secure location.
: The authors declare that they have no competing interests.
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