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Patients receive an envelope according to their inclusion number in which allocation is documented.
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27 Concealment of allocation was documented in two studies as use of sealed envelopes 24 26; it was not reported in the other two studies.
The allocation of the patients is documented in a separate reference list that is accessible only to the implementing study personnel.
This is documented".
"Nothing here is documented.
"Everything is documented".
For example, a study of 7422 randomised trials published in Chinese medical journals found that important methodological components such as sample size calculation, randomisation sequence, and allocation concealment were documented in only a small minority of trial reports (1%, 8%, and 0.3%, respectively).
The corresponding power allocation and band assignment are documented in Table3.
We recommend that the details of and justification for the allocation process being employed are documented and given in the final trial reports.
Group allocation is then documented on an extra sheet of the case report form.
Thus, items on compliance, distribution of co-interventions and timing of outcome assessment are given the same weight as concealment of allocation, which, along with blinding, has been documented as the most important safeguard against bias [ 3, 4].
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