Text and Data Mining valid from 2019-09-06
Received: 25 April 2019
Accepted: 27 August 2019
First Online: 6 September 2019
Ethics approval and consent to participate
: This trial is registered with EudraCT Number 2008–001009-41 and received ethics approval by London Hampstead Research Ethics Committee and Medicines and Healthcare Regulatory Agency reference number 08/H0720/90. All participants provided written informed consent to participate in the study. The study adheres to CONSORT guidelines.
: Not applicable.
: None declared. The authors declare no competing interests. The results presented in this article have not been published previously in whole or part, except in abstract form.