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Also, four patients who agreed to participate had to be withdrawn before randomisation because of a sudden change in either their condition or the doctor's opinion.
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That application was withdrawn before the Durban meeting.
(But four lots were withdrawn before the auction).
No patient was withdrawn before treatment assignment (see Figure 1).
Cooling may be discontinued if any of the following occurs: Parents request that cooling be withdrawn prior to 72 hours after randomisation.
If consent is not obtained within 24 h of randomisation, the baby will be withdrawn from the study.
If participants withdraw before they have been randomised they will be replaced, those withdrawing or being withdrawn after randomisation will not be replaced.
Of 179 patients randomised to the trial, eight were withdrawn post randomisation (see Potter et al. [ 23] for details of post-randomisation exclusions).
The participants who are withdrawn after randomisation will be followed for outcomes.
One participant from each group was withdrawn after randomisation on the advice of Data Monitoring and Ethics Committee.
Two consenting participants in a single care home were withdrawn by the care home manager before randomisation to receive end of life care.
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