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Registration and allocation will be implemented at the registration centre.
Enrolment and allocation will be carried out by the research fellow.
Randomisation will be undertaken using a computer generated sequence and allocation will be concealed using sealed, opaque envelopes.
The randomisation and allocation will be conducted by an independent data manager in the York Trials Unit, University of York, using a computer program.
To ensure allocation concealment, the block size will not be disclosed and allocation will be assigned using sequentially numbered, opaque, sealed envelopes.
After the participant passes the screening process and completes the baseline assessment, an envelope will be opened and allocation will be revealed by an independent person (figure 1).
Similar(51)
Practices and allocations will be randomly sampled without replacement and paired to generate allocation groups.
EDs and allocations will be randomly sampled without replacement and paired to generate allocation groups.
Interactions between subgroup variables (past falls and mobility-related disability) and group allocation will be tested, and in the case of a significant interaction, the comparison between the intervention group and control group will be reported within the subgroups.
A randomized controlled trial will be conducted and concealed allocation will be used to allocate patients to either metal-on-polyethylene or metal-on-metal cementless total hip arthroplasty.
All participants and group allocation will be coded, sociodemographic data coded, and outcome questionnaires scored, and all data entered into the Statistical Package for the Social Sciences database for analysis following data cleaning and checking for errors.
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