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If consenting, the patient will be randomised using a remote randomisation service, with equal probability to either minimal intervention or stepped care.
Participants will be randomised using a computerised simple randomisation scheme in a 1 1 ratio to intervention and control arms.
Eligible women will be randomised using a computer-generated randomisation sequence to one of the two arms: continuous computer analysis of fetal monitoring signals with real-time alerts (intervention arm) or continuous CTG monitoring as previously performed (control arm).
Participants will be randomised using a secure (24 h) web-based randomisation programme controlled centrally by the Clinical Trials Research Centre.
Participants will be randomised using a bespoke secure (24 h) web based randomisation programme controlled centrally by the CTRC, University of Liverpool.
Patients will be randomised using a computerised number generator through the stratified block randomisation method of the Statistical Analysis System SASS) package (V.9.1.3; SAS Institute Inc ,Cary, North Carolina, USA) by a statistician with no clinical involvement in this trial.
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Using each GP as a unit for randomisation, patients who responded at baseline were randomised using a permuted block randomisation procedure.
After calculating the patient's STarT Back tool score from the postal questionnaire, the clinic administrator telephones the Primary Care Musculoskeletal Research Centre randomisation service.[ 15, 34] Patients are randomised using a stratified block randomisation method according to Centre and risk subgroup.
Consecutively enrolled patients were randomised using a central randomisation scheme generated by an Interactive Voice Response System.
9 Patients were randomised using a pregenerated randomisation code in a 1 1 ratio to receive an intramuscular injection of either 500 U abobotulinumtoxinA or placebo.
Participants are randomised using a block randomisation method with sets of numbered, sealed envelopes prepared by the trial statistician (ATP), with the order of the sequences used being verified afterwards.
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