Footnotes

• We are grateful to all the international general practices and practitioners and women who participated in WISDOM.

• Other members of the WISDOM team: M Abdalla, B L DeStavola, statistical analysis, department of epidemiology and population health, London School of Hygiene and Tropical Medicine; P Allen, H Balen, R Bastick, H Brown, K Foulger, S Fox, V Glynn, A Hall, L Hand, A Hill, C Leathem, W Mackinnon, E Marshall, A Williams, regional training nurses; N Collins N, B O’Conner, trial managers; J H Darbyshire, director; M Ghali, P Furness, M Z Islam, software design for electronic data collection and management; K Harrild, statistical analysis and data management; C Knott, L Taylor, implementation of trial protocol and management, research nurse support; M A Walgrove, contributed to protocol, developed manual, nurse support; H C Wilkes, statistical design, C-Q Zhu, statistician; S R Zuhrie, development of trial protocol and medical advice; MRC General Practice Research Framework, London; E Griffith, data manager and pharmacy control; P Ryan, co-investigator in South Australia, co-grantee of Australian funding, discipline of public health, University of Adelaide, Australia; P Komesaroff, senior investigator in Victoria, University of Monash, Victoria, Australia; Marley J, senior investigator in NSW and co-grantee of Australian funding, University of Newcastle, New South Wales, Australia; B J Paine, trial coordinator, discipline of obstetrics and gynaecology, University of Adelaide; N P Stocks, medical director, discipline of general practice, University of Adelaide; A Dowell, senior investigator, S Rose, co-investigator, department of primary healthcare and general practice, Wellington School of Medicine and Health Sciences, New Zealand.

• Contributors: AJW contributed to the selection of the health related quality of life instruments, was responsible for overseeing the collection of the quality of life data, and contributed to the analysis and interpretation of data and drafting of manuscript. MRV was the WISDOM principal investigator and co-wrote the application for funding with AJW. TWM was responsible for trial design, protocol development, trial procedures, and overall management, contributed to analysis and interpretation of data and drafting of manuscript, and approved the final paper. JK performed statistical analyses and contributed to interpretation of data. DF performed statistical analyses and contributed to interpretation of data and drafting of manuscript. BAL was the principal investigator in New Zealand, contributed to trial design, trial procedures, analyses, and interpretation of data and drafting of manuscript. AHM was the principal investigator in Australia and contributed to trial design, trial procedures, analyses and interpretation of data, and drafting of the manuscript. SKM contributed to revision of the protocol, trial conduct, analysis and interpretation of data, and drafting of the manuscript. JM was responsible for training and coordination of UK research nurses and quality control. TWM was principal investigator in UK and had overall responsibility for studies in the MRC general practice research framework (until retirement in 2001). MRC is guarantor.

• Funding: UK Medical Research Council, British Heart Foundation, Department of Health for England, Scottish Office, Welsh Office, Department of Health and Social Services for Northern Ireland, Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Australasian Menopause Society, National Health and Medical Research Council, National Heart Foundation of Australia, Cancer Council of South Australia, NHS research and development executive (service support and excess treatment costs), Cancer Society of New Zealand (Wellington Division). The UK MRC, in collaboration with the other UK funders established a trial steering committee (TSC) with an independent chairman and an independent data monitoring and ethics committee (DMEC). The TSC monitored the progress of the trial reporting annually to MRC. The DMEC considered unblinded group data, took account of external developments relevant to the progress of the trial, and made recommendations to the TSC. The funders in Australia and New Zealand monitored local progress and received reports on progress from the UK TSC. The principal investigators from Australia and New Zealand were non-voting members of the UK TSC.

• Competing interests: AHM has received research grants and lecture honoraria from various pharmaceutical companies but not in association with this study. BAL has received research and travel grants and lecture honoraria from various pharmaceutical companies but not in association with this study.

• Ethical approval: South Thames regional health authority multicentre research ethics committees and relevant local research ethics committees; human research ethics committees for the Universities of Adelaide, Newcastle, and Monash, and the Royal Australian College of General Practitioners’ national research and evaluation ethics committee; Wellington regional ethics committee and Auckland and Canterbury ethics committees.

• Provenance and peer review: Not commissioned; externally peer reviewed.