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Allocation concealment will be assured by using a remote telephone allocation service through the university research department.
Automation of the process (in addition to telephone allocation where available) reduces the propensity for conscious or unconscious interference with the allocation procedure.
A computer-generated randomization program was used and treatment allocation was properly concealed using automated telephone allocation service (Paravox) provided by an independent organization.
If the woman agrees, the consent form is signed and the woman is registered as a trial participant and the remote telephone allocation service at the university is contacted for random allocation.
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Randomisation will occur by telephone and allocation communicated securely to each Trust Pharmacy which will securely over-package the study drug to conceal allocation.
The randomisation is administered by an independent body (the NHMRC Clinical Trials Centre's Randomisation Service), who are contacted by telephone for the allocation of each patient to a study arm.
After preparing a random sequence, subjects will be allocated to the trial groups using an implementation method such as numbered containers, central telephone line, or allocation by a person who is not involved in the main research and patient care (the encoder).
The statistician then telephoned the treatment allocation to the trial manager, who informed clinical sites.
Research nurses blinded to group allocation telephoned all participants at 12 and 24 weeks postpartum to assess trial outcomes.
A research assistant blinded to group allocation telephoned participants if they failed to return the calendar to ascertain whether they had fallen.
8 Trained research staff, blinded to treatment allocation, telephoned patients three months after the onset of acute lung injury to provide a reminder about the follow-up study and to obtain updated contact information for the patient and designated proxies.
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