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Article History

Received: 2 August 2017

Accepted: 13 March 2018

First Online: 27 March 2018

Ethics approval and consent to participate

: Investigators will ensure that this study is conducted in accordance with the current principles of the Declaration of Helsinki (October 2008). The conduct of this study will be in full compliance with the relevant regulations and principles of Good Clinical Practice and equivalent guidance from our trial countries. Ethical approval has been granted by the Biomedical Sciences, Dentistry, Medicine and Natural and Mathematical Sciences Research Ethics Subcommittee at King’s College London (LRS-14/15-1484). Local ethical approval from each cluster has been granted:In accord with recognised procedures for stepped-wedge trials [–], primary outcome data will be collected centrally rather than individually. Institutional-level consent is appropriate considering the following:Institutional-level consent will be sought to adopt the CRADLE intervention at the start of the trial (time point zero), prior to implementation of the intervention at subsequent time points.Informed written consent will be sought from HCP participating in interviews, focus group discussions and the evaluation of appropriateness of referrals log.

: Not applicable.

: The authors declare that they have no competing interests.

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