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Pending the passage of the health and social care bill, the next allocation will be placed into the hands of the NHS Commissioning Board.
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Participants' allocations will be placed in opaque, sequentially numbered and sealed envelopes which will be kept in Australia.
The process will be coordinated centrally by a Chief Investigator independently of GP recruitment, intervention implementation, or data collection processes, and who will conceal the initial allocation process from project officers (e.g., allocation numbers will be placed in sealed, serially coded envelopes, and housed in a locked cabinet).
To avoid revealing study group allocation to the blinded assessor, exercise diaries will be placed in a locked box at the study site reception.
Pre-prepared cards indicating group assignment will be placed in sealed opaque envelopes and drawn as a lottery by a third party for allocation to treatment groups.
The stratified random allocation schedule will be generated by a person not otherwise involved in recruitment, assessment or treatment of subjects and the randomisation sequence will be placed in sequentially numbered, sealed envelopes.
Allocation will be concealed by placing the randomized designations in white envelopes, which will be sealed and opened only after inclusion of the patient in the study.
Each patient's allocation will be concealed using sequentially numbered, sealed and placed in opaque envelopes.
Treatment allocation will be recorded on a folded piece of paper, placed in sealed, opaque envelopes, held by non-study personnel.
Allocation will be concealed from the research team recruiting the flats and participants, as randomisation will only take place after baseline measures have been accomplished.
From 2009 this allocation will be on the basis of metrics.
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