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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.
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WB and GJT participated in the design of the study, in the implementation of the study, and in writing the manuscript.
GV participated in the design of the study, and participated in the implementation of the study.
MS and JF participated in the implementation of the study and contributed to subject recruitment, sample and data collection.
IK and RN conceived the study and design; IK, JL, OP, MM, and BS participated in the implementation of the study and data analysis.
HG has participated in the implementation of the study.
ANA, AW, SZF participated in the implementation of the study.
MCP, EAD, WJ, ZZ participated in the implementation of the study.
KLC participated in the implementation of the study.
EC participated in the implementation of the study, in the qualitative analysis, and helped to draft the manuscript.
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