Data will be made available in line with the policy and procedures described at.
The Steering Committee will have the right to review and comment on any draft manuscripts before 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 (eg, relating to data protection and privacy). Deidentified participant data will be made available to researchers registered with an appropriate institution within 3 months of publication. As described in the protocol, the trial Steering Committee will facilitate the use of the study data and approval will not be unreasonably withheld.
The protocol, consent form, statistical analysis plan, definition and derivation of clinical characteristics and outcomes, training materials, regulatory documents, and other relevant study materials are available online at.
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