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Allocation of the trial intervention will take place at the end of the initial surgery so that there is no difference between the groups in terms of surgical risk.
34 Owing to an unequal allocation of the trial participants to one of the two groups in the beginning of the trial, the block size was reduced from 12 to 4 (see 'Randomisation' section).
Owing to an unequal allocation of the trial participants to one of the two groups in the beginning of the trial (there were only a few participants in one of the groups), the block size was reduced from 12 to 4 and a stratification variable (HDRS score ≥22 points) was removed.
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SUSARs will also be reported to the DMEC chair along with the treatment allocation group of the trial subject and a cumulative count of SAE and SUSAR frequency in each trial arm.
15 16 While maintaining the integrity of the 2 2 1 randomisation allocation of the ACUDep trial, 16 for the purpose of this substudy participants were divided into two groups according to their response to the EQ-5D pain statements at baseline: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort.
The primary analysis in an RCT typically reports an intention to treat estimate, which is the difference in allocation between arms of the trial based on allocation, rather than the treatment the participant received.
They will continue to provide DSME to their patients irrespective of their allocation to one of the trial arms.
For allocation of the participants to the trial groups, a computer-generated list of random numbers was used prepared by an independent biometrical institute; randomization sequence was stratified by center with a 1 : 1 allocation using random block sizes of 4. Placebo and verum were in vials, packed in two boxes per patient.
It is important that the person performing the allocations is independent of the trial team.
A central drug administrator takes charge of the overall allocation of all trial drugs; drug administrators of sub-centres take charge of the allocation and recovery of the drugs of their own centres.
To test whether staff remained blind to group allocation, we asked them to guess group allocation at the end of the trial.
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