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Today, the Education Department uses an allocation code management system to do the work.
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With written informed consent, eligible patients were randomly assigned in a 1 1 manner to receive either structured care or usual care using a computer-generated allocation code with equal numbers in each group within the same hospital.
A web based program generated a unique number with allocation code after entry of the patient's initials and date of birth.
Thereafter, the researcher (GJDB) opened pre-prepared numbered opaque sealed envelopes containing the treatment allocation code from a randomization list produced by independent physician.
The allocation code appeared after a patient's initials were entered into the randomisation program.
Each participant was assigned a unique participant number, and the allocation code was kept in numbered sealed opaque envelope originating from the independent researcher.
An independent researcher revealed the allocation code after the analyses were run.
The allocation code was kept by an independent researcher (JG) and was revealed only after data analysis had been completed.
Prior to the creation of the randomisation allocation code, each participant will elect a programme location, either location A or B. Two randomisation codes will be created, one for each location.
Participants were allocated remotely by the York Trials Unit, with the allocation code concealed from the recruiting researcher, to three groups in the proportions of 2 : 2 : 1 to acupuncture, counselling and usual care alone, respectively.
The codes will be kept at the central administration site which is located 'off-site.' Participant names will be allocated to either the test or control group using the randomised allocation code for each location.
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