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For all quantum chemical calculations, the solvents specified in the study by Tang et al. [13] have been considered.
As specified in the study protocol (Fig. 1), the accuracy analysis required a minimum monitoring time of 48 h or at least 12 comparative readings.
Group-sequential testing in agreement studies offers the possibility of early termination of the trial, implying potential time and resource savings, but timing of and decision rules for interim analyses must be a priori specified in the study protocol in order to secure the experiment-wise type I error probability.
These differences in favor of the Headstrong group might have been significant were the groups as large as those specified in the study's sample-size calculations but this cannot be proven in the current study.
The exact mechanism for the change was not specified in the study.
These items were assessed as specified in the study protocol.
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The OT part of the program of Sullivan et al contains "increasing activity involvement" but it is not specified in the study-report what precisely the therapeutic actions of the occupational therapist were [ 22].
There were 262 (35.6%) reported infections on mTOR inhibitors in which the type of the infection was not otherwise specified in the studies.
Blinded adjudication of the CV events was not pre-specified in the study protocols; therefore, events were identified retrospectively using the pre-specified list of preferred terms independent of whether or not the events had occurred.
We delineate what is necessary to specify in the study protocol to ensure the validity of the statistical procedure and what can be kept implicit in the protocol so that more flexibility can be attained for confirmatory phase III trials in meeting regulatory requirements.
All data was analyzed according to criteria pre-specified in the study protocol.
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