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Before randomisation, the women who volunteered to participate signed an informed consent form approved by the University of Toronto’s Human Experimentation Committee.

The study was conducted in 15 screening centres in six Canadian provinces (Nova Scotia, Quebec, Ontario, Manitoba, Alberta, and British Columbia).

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Setting 15 screening centres in six Canadian provinces,1980-85 (Nova Scotia, Quebec, Ontario, Manitoba, Alberta, and British Columbia).

Participants 89 835 women, aged 40-59, randomly assigned to mammography (five annual mammography screens) or control (no mammography).

Randomisation was individual and stratified by centre and five year age group.5 Irrespective of the findings on physical examination, women aged 40-49 were independently and blindly assigned randomly to receive mammography or no mammography.

Those allocated to mammography were offered another four rounds of annual mammography and physical examination, those allocated to no mammography were told to remain under the care of their family doctor, thus receiving usual care in the community, although they were asked to complete four annual follow-up questionnaires.

Mammogram detected non-palpable breast cancers are smaller on average than clinically palpable breast cancers.

Small breast cancers confer a better prognosis than large ones.

During the entire study period, 3250 women in the mammography arm and 3133 in the control arm had a diagnosis of breast cancer, and 500 and 505, respectively, died of breast cancer.

Thus the cumulative mortality from breast cancer was similar between women in the mammography arm and in the control arm (hazard ratio 0.99, 95% confidence interval 0.88 to 1.12).

Participants were recruited to the study by a general publicity campaign, by reviewing population lists and sending personal invitation letters, by group mailings, and through family doctors.4 Women were eligible if they were aged 40-59, had had no mammography in the previous 12 months, had no history of breast cancer, and were not pregnant.

Recruitment was planned to enrol 50 000 women aged 40-49 and 40 000 aged 50-59 years.

It was not deemed ethical to include a no screening arm for women aged 50-59.