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The risks to participants in this trial are small, and no serious adverse events or side effects attributable to the treatment provided are expected. Patients and GPs will be encouraged to report all potential adverse events and incidents of serious pathology (and method of discovery) observed amongst trial participants to the research team on a continuous basis during the study, including through each follow-up survey. Adverse event reports will be reviewed by the DMC (detailed below).
Copyright and License information: The Author(s). ©2017
Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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