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Hence, no recommendation to administer fibrinolytics as a standard of care in all OHCA-patients could be generated from this trial.
The hypothesis generated from this trial will have to be confirmed in an ITT population in a prospective confirmatory trial.
We anticipate that the size of the effect on the primary outcome based on the data generated from this trial will enable us to estimate the sample size for a large multicentre trial.
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Effect sizes generated from this pilot trial will assist in powering a future definitive trial.
Publications generated from the trial will be attributed to the FACT TMG, which will consist of all those who have wholeheartedly collaborated in the trial.
The nutrition protocol was adapted from the protocol used in the Scandinavian Glutamine Trial [ 12] because hypotheses behind the present protocols were generated from that trial.
Only the research team will have access to the study data; data generated from the trial will be available for inspection by the HREC and funders on request.
The CO2 generated from use of fuel at the study centres ranged from 9.3 to 32.2 tonnes (average 18.1 tonnes per trial), and that generated from the trial team commuting to work ranged from 11.5 to 35.0 tonnes (average 20.9 tonnes per trial).
Only the research team will have access to the study data, data generated from the trial will be available for inspection by the ethics and R&D committees on request.
All the patient data generated from the trial will be recorded online via an electronic case report form (eCRF), on an online Macro System, prepared and run by the CTU, KCL, and will be accessible to all study sites via http://www.ctu.co.uk.
The basic aims of the CTD are to protect participants in clinical trials and to ensure that data generated from these trials are accurate and verifiable, which are important in all trials.
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