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Article History

Received: 28 September 2019

Revised: 27 January 2020

Accepted: 19 February 2020

First Online: 15 April 2020

Ethics approval and consent to participate

: The protocol was approved by the Independent Scientific Advisory Committee (ISAC) of the MHRA (ISAC protocol number 16_164A2A, available from the authors on request). Ethics approval for observational research using the CPRD with approval from ISAC was granted by a National Research Ethics Service committee (Trent Multiresearch Ethics Committee, REC reference number 05/MRE04/87). The CPRD has broad National Research Ethics Service Committee (NRES) ethics approval for purely observational research using the primary care data and established data linkages. The study was performed in accordance with the Declaration of Helsinki.

: Not applicable.

: This study is based on CPRD data and is subject to a full licence agreement which does not permit data sharing outside of the research team.

: The authors declare no competing interests.

: B.D.N. is supported by National Institute for Health Research (NIHR) Doctoral Research Fellowship number (DRF-2015-08-18). P.A. is an NIHR senior investigator and is funded by NIHR Oxford Biomedical Research Centre and the NIHR Applied Research Collaboration (ARC) for Oxford and Thames Valley. W.H. is co-Principal Investigator of the multi-institutional CanTest Research Collaborative funded by a Cancer Research UK Population Research Catalyst award (C8640/A23385). F.D.R.H. acknowledges his part-funding from the National Institute for Health Research (NIHR) School for Primary Care Research, the NIHR ARC for Oxford and Thames Valley, the NIHR Oxford Biomedical Research Centre (BRC, UHT), and the NIHR Oxford Medtech and In-Vitro Diagnostics Co-operative (MIC). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health.