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These charts will be assessed and total antipsychotic dosage recorded by the research team member who is blinded to allocation of the intervention.
An external off-site biostatistician (AH) will only notify the intervention team members of the allocation of intervention according to a 1 1 randomisation plan 1 working day before the appointed time of the RCF visit.
We sent two postal reminders; if necessary this was followed by a phone call from the study team member, who was blind to treatment allocation, to collect the primary outcome and modified Von Korff scales [ 35].
A team member uninvolved in the study made the random allocation manually with the use of a paper-based lottery.
The random allocation sequence was generated by one team member and verified by a second team member.
To reduce the risk of unblinding of patient allocation, metHb concentrations will be measured by a research team member who will not be involved in other patient assessments.
After a patient was deemed eligible, an operating room team member accessed the Web site, entered demographic information, and announced the assigned allocation.
Neither the TSC nor any other team member involved with running the trial will have sight of accumulating data by allocation during the course of the trial.
Allocation concealment was achieved by ensuring that randomisation was performed by a study team member not involved in participant recruitment.
Group allocation is made by reference to computer-generated blocked randomization lists prepared by a team member who has no involvement in delivering the interventions.
The random allocation sequence will be generated using an online random number generator distributed by a research team member not involved in participant recruitment.
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