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This has important clinical relevance since the root resorption detection on the radiograph is considered blinded.
The radiologist was considered blinded to the objective of the present study, as at the time the radiologic reports were generated, it was not apparent that this data would be collected retrospectively for analysis.
Trial participants or clusters of participants in an inactive 'usual care' control group might also be considered blinded if they do not know that they are part of a trial.
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In instances where blinding was not feasible, we considered blinding to have been appropriately done if at least one group was unambiguously reported as blinded [ 3, 37, 38].
In these instances, where blinding is not feasible, we considered blinding to have been done appropriately if at least one specific group was unambiguously reported as blinded [ 3].
After the unblinding, the study was considered single blinded although both participants and field investigators remained blinded.
In hyperbaric treatment studies, the study is considered double-blinded if the study participants and the evaluators of outcome measures are both blinded to group assignment (as they were in this study), even though the hyperbaric technician is aware of the assignment [ 37, 38].
As emphasized in a recent IOM report, future trials should consider partially-blinded factorial designs to evaluate the utility of adherence interventions to inform planning of future studies and forestall investments of time, effort, and funding of approaches that are of doubtful yield [ 10].
Methods were identified to reduce unblinding through careful attention to the type of data collected at unblinded measurement points; the content of interviews should be carefully considered when designing blinded-trial protocols.
This occurred 42 weeks after the administration of the third dose and the blinded investigator considered the stillbirth unlikely to be related to vaccination.
Five additional patients (3 verum, 2 placebo) were retrospectively excluded due to protocol violations (e.g. allocated in infection group while failing predefined infection criteria) and considered "invalid" in the blinded reviewing process (Figure 1).
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