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All RCTs described the procedure of randomization and blinded participants and researchers, and all trials reported allocation concealment and blinding of outcome assessment.
The specific procedure of randomization was described in detail in 4 of these studies.
The procedure of randomization of treatment has been previously described [ 15].
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The randomization procedure of participants is determined by a computer randomization feature which automatically allocates the patient to one of the treatment strategies.
In this section, the settings of randomization procedure in SDPVN-MSMRS B and SDPVNMSMRS A are N c =2 and N l =14.
These letters contain a detailed description of the study procedure (especially the necessity of randomization).
The study group received the EBV implantation procedure within three weeks of randomization, and continued optimal medical management and exercise similar to the control group.
Second, in the absence of randomization procedures the influence of unknown biases, e.g. through patient selection, cannot be assessed.
First, the methodological shortcomings of the included studies, such as small sample sizes, unclear description of the study design, incomplete reporting of randomization procedures, and the lack of clear definition and description of the strengths-based approach.
Nevertheless, the impact of their evidence is weaker given the absence of a control group, the lack of randomization procedures, and a high risk of selection bias (e.g. participation in the intervention was voluntary).
The data were acquired and published over a period of many years, and the studies involved heterogeneous populations, different study designs, and in some cases inadequate or no description of randomization procedures.
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