Methods
RECRUITMENT
A multistate Phase III RCT was conducted with eight Australian sites, three in Perth, WA and five in Sydney, NSW. CONSORT guidelines guided recruitment, monitoring of response rates, participant withdrawal and reporting.Ethics approval was gained from participating sites (NSW: HREC 16/105; SJOG: 671; SCGH: 2013-172; Curtin University: HR 17/2013). Trial registration number: Australian and New Zealand Clinical Trials Registration (ACTRN) 12612001147875. We have previously published the protocol for the RCT [