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We are ensuring concealment of allocation by using a centralised 24 h computerised randomisation system that will allow internet-based randomisation.
Using the computerised randomisation system 276 participants were allocated to the Control Group and 282 to the Intervention Group.
Randomisation into one of the two study groups will be carried out by the study statistician using an independent computerised randomisation system with a randomly sized block design with block sizes of 2, 4 and 6.
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Randomised sample (simple computerised randomisation stratified by sex) of men and women from 40 to 90 years of age in the FRIDEX cohort for 10 years since the baseline DXA and QRF.
Randomised sample (simple computerised randomisation stratified by sex) was obtained of women from 40 to 90 years of age in the FRIDEX cohort for 10 years since the baseline DXA and QRF.
Computerised randomisation will define the sequence of the study groups.
Randomisation will occur at 360/7 396/7/7 weeks gestation via a computerised randomisation programme at the Clinical Trials Unit, University of Nottingham.
Randomisation was stratified according to the participating centre only, using a 1 : 1 computerised randomisation.
Allocation to groups will be managed by the Flinders University statistician who provides a randomisation service using computerised randomisation software.
Participants will be assigned to one of two treatment groups via a computerised randomisation programme at the Clinical Trials Unit, Nottingham University Hospitals NHS Trust.
Computerised randomisation in permuted blocks of sizes 4 and 6 (arranged unpredictably) was stratified by centre, practice and specialty.
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