Data availability
Data will be available for sharing after the main trial publication is released. All requests for data will be considered by the Chief Investigator/TMG and, if approved, shared via a data sharing agreement. Decision making factors will include: Data use is in keeping with patient consent. Confidentiality is maintained at all times i.e. no patient identifiable data, such as date of birth will be provided. Data are appropriate for intended purpose. Compliance with legal and ethical requirements is maintained.