Availability of data and materials
Records management is guided by systems implemented by the NHMRC Clinical Trials Centre, in line with requirements for record keeping in the NSW private sector, medico-legal requirements and the NSW State Records Act 1998. Trial documents are stored under medical records conditions for 15 years post publication in the secure UNSW Shared File storage, with access restricted to the appropriate researchers who have access to UNSWnetworks. On the case report forms and other documents, a unique study code is used to identify the records. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.