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The statistical analysis is blinded and the statistician is not aware of the intervention allocation of participants during the analysis; this is done with the two groups, coded as X and Y.
In addition, although recruiters were blinded to the intervention allocation of participants, the assessors could not be blinded since it would have been impossible to insure that participants did not mention that intervention they had received at the time of assessment.
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There was no significant effect of the intervention allocation on the change in the concentrations of any of the other micronutrients studied.
Recruitment of patient participants into professional-cluster trials can result in selection bias from the selective recruitment of patients by individuals who are often aware of intervention allocation (for example, Farrin 2005 [ 11]).
A limitation of this study is that it is not possible to blind the employees and health care providers for the intervention allocation, because of the nature of the workplace intervention.
Eligible healthcare consumers are randomly assigned to the intervention or control group using a computer generated random number sequence in randomly assigned blocks (block sizes 2, 4 and 8) with intervention allocation ratio of 1 1 [ 32].
For sensitivity analyses, we will define 'high risk of bias' based on each of three criteria, namely inadequate concealment of intervention allocation, inadequate blinding of outcome assessment and substantial loss to follow-up and/or withdrawals from allocated interventions.
Notably, all were of a cluster design, with the unit of randomisation for intervention allocation being groups of practitioners, such as regions, practices or clinical teams.
First, data collection staff became 'unblinded' over time for 15 of the 35 homes despite constant reminders to nursing home staff ahead of data collection periods of the importance of maintaining confidentiality of intervention allocation.
Owners were blinded to treatment allocation until the end of the study period (6 months), and the clinician and technician responsible for recording the outcome measures were blinded to intervention allocation until completion of data analysis.
Statistical analysis will include: Descriptive statistics of the patient characteristics within each treatment group A CONSORT flow diagram of enrolment, intervention allocation, and follow-up Tables of toxicities at each timepoint (baseline, end of CRT (including all those during treatment), 30 days post-surgery, and then during later follow up.
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