Results

DATA SHARING

The protocol, consent form, statistical analysis plan, definition and derivation of clinical characteristics and outcomes, training materials, regulatory documents, and study materials are available on this website.

As described in the protocol, the trial steering committee will facilitate the use of the study data and approval will not be unreasonably withheld. De-identified participant data will be made available to bona fide researchers registered with an appropriate institution within three months of publication. However, the steering committee will need to be satisfied that any proposed publication is of high quality, honours the commitments made to the study participants in the consent documentation and ethical approvals, and is compliant with relevant legal and regulatory requirements (e.g. relating to data protection and privacy). The steering committee will have the right to review and comment on any draft manuscripts prior to publication. 

Data will be made available in line with this policy. Please note that we are working with NHS data asset owners to ensure trustworthy onward data sharing, so we cannot currently share trial data derived from those sources. When we are in a position to share these data, they will be shared via the Infectious Diseases Data Observatory.

• Protocol v25 (23 May 2022)
• Statistical Analysis Plan v4 (20 September 2022)
• Paediatric Statistical Analysis Plan v1.1 (31 August 2021)
• Definition and Derivation of baseline Characteristics and Outcomes v5 (23 August 2022)

Archive of previous versions of the study protocol and statistical analysis plan and definitions