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Article History

Received: 28 January 2020

Accepted: 16 July 2020

First Online: 25 July 2020

Ethics approval and consent to participate

: The study was approved by South West 4 Research Ethics Committee (10/HO102/51). The National Information Governance Board approved the use of routinely-collected patient data without specific consent and North Bristol NHS Trust acted as Sponsor. The database was anonymised by removal of all patient identifiers before being released for statistical analysis, and data collection forms were destroyed. Data entered onto the web-based system was encrypted and uploaded into a central study database. Staff other than central study managers could only access their own centre’s data through the web interface, and access to interim downloads of the central database was restricted to central data management staff.

: Not applicable.

: MW reports personal fees from Astra Zeneca, Bayer, Durata, Nabriva, Roche The Medicine Company, Phico Therapeutics, MotifBio, Aicuris, Allergan and grants and personal fees from Pfizer, Abbott, and European Tissue Symposium, during the conduct of the study; grants and personal fees from Actelion, Astellas, Sanofi Pasteur, Summit, Seres, Biomerieux, Da Volterra, Qiagen, Alere and personal fees from Merck, Valneva, Synthetic Biologics, Meridian and grants from Micropharm, outside the submitted work.PW reports personal fees from Roche, MSD and grants from Shionogi, outside the submitted work.The following authors declare that they have nothing to disclose: RNE, KP, CR, RR, MS, RH, FKG AM.