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MD contributed to the implementation of study in Georgia and comments on the manuscript.
MD, GG and AZ contributed to the implementation of study in Georgia.
TDN was the principal investigator who conceptualized the study, and was responsible for the overall supervision of the study and participated in the implementation of study, data analysis, and the writing of the manuscript.
246 Based on the risk of bias associated with some methods of sequence generation and inadequate allocation concealment, trial investigators should strive for complete separation of the individuals involved in the steps before enrolment (sequence generation process and allocation concealment mechanism) from those involved in the implementation of study group assignments.
We opted for a cluster-randomized trial, with randomization at the clinic level in order to reduce the risk of contamination, mitigate confounding with clinician communication style, and facilitate the implementation of study procedures and of the decision aid in each practice [ 12].
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Here we describe details of the implementation of Study-II concepts and discuss their efficacy.
There is nevertheless still scope to improve the study design, the implementation of studies and their analysis and reporting in conflict settings.
P.M. contributed to the implementation of the study, conducted field data collections and manuscript editing.
H.A.B.P. contributed to the implementation of the study, conducted field data collections and manuscript editing.
FY and SM assisted in designing the study and supervised the implementation of the study.
GV participated in the design of the study, and participated in the implementation of the study.
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