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A high recruitment rate will be required for the trial to complete on schedule.
The RCT comprises an exploratory trial, to complete the modelling and piloting phase of the MRC 4-phased framework [ 26].
Unfortunately, with the preference for less-invasive therapies and procedural selection based on operative risk, it might be a difficult trial to complete with regard to patient recruitment and enrollment.
The Ethics Committee did not approve the proposed use of a twofold written consent incorporating a request for those who declined to participate in the trial to complete a baseline questionnaire at the hospital.
To interpret the effects of interventions better, future trials need to characterise the population from which participants have been recruited by collecting data about non-responders, encouraging respondents who do not wish to take part in the trial to complete baseline questionnaires, and investigating the effect of measurement itself on adherence and clinical risk.
Owing to the failure of this trial to complete accrual as planned, and therefore answer the question originally posed, it is of utmost importance to obtain reliable phase III evidence of the relative benefits of continuous chemotherapy vs intermittent chemotherapy with a chemotherapy-free interval in the treatment of ACRC.
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The categories number of trials administered, total number of correct answers, total number of errors, number of perseverative responses, number of perseverative errors, number of categories completed, number of trials to complete the first category, and failure to maintain set were considered for analyzing gains related to cognitive flexibility in the present study.
Scores were based on number of trials administered, total number of correct responses, number of errors, number of perseverative responses, number of perseverative errors, number of non-perseverative errors, number of categories completed, number of trials to complete the first category, conceptual level responses, failure to maintain set, and learning to learn.
The SUPPORT trial was the first of the oxygen trials to complete recruitment.
Administration of EtOH also showed a significant effect [F (1,42) = 6.373; p < 0.01], as the groups treated with EtOH needed more trials to complete the task (p < 0.01).
Following previous research (11), we assessed: 1) number of categories completed, 2) overall trials administered, 3) perseverative errors, 4) nonperseverative errors, 5) trials to complete the first category, and 6) failure to maintain set.
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