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The study statistician generated the random sequence (based on simple randomisation) by using a computerised random number generator; this was concealed from all study personnel throughout the study.
Most prescription errors could possibly have been avoided by using a computerised chemotherapy prescribing system [ 26], but such a system is not available in all French hospitals.
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Standardised delivery of the interventions will be assured by all interventions being delivered by one clinical research fellow using a computerised intervention.
Participants above the age of 60 years were first identified using a computerised list and by door-to-door survey.
According to a stratified randomisation scheme (using a computerised list maintained by the sponsor), investigators assigned patients in a 2 : 1 ratio to treatment with CDDP/epi gel or placebo gel, within stratum I (target tumour volume <5 cm) or stratum II (target tumour volume >5 but ⩽20 cm).
Behaviour was recorded onto video tapes for 1 h either side of treatment for analysis using a computerised event recorder.
Electromyography (EMG) activity was recorded from 5 muscles of the dominant arm-shoulder region using a computerised data recording and analysis system.
Five fields of tumour sections were analysed at low magnification using a computerised image analyser (Image-Pro Plus, Media Cybernetics, MA, USA).
Patients were randomly assigned to intervention or control by using a web based computerised randomization plan generator http://www.randomization.com.
We are ensuring concealment of allocation by using a centralised 24 h computerised randomisation system that will allow internet-based randomisation.
This study was based on mixed methods using a questionnaire, computerised psychological test and hair analysis for selected performance enhancing drugs.
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