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Exact(10)
The assessment of toxicity and disease progression events was specified in the trial protocol according to standard definitions.
A record of all contacts with trial participants is kept to examine potential for interactions with patients not specified in the trial protocol.
The initial model, as specified in the trial protocol, resulted in a treatment effect of increased hippocampal atrophy over a 78-week duration.
For simulation, information about the underlying trial design can either be specified in the Trial Design section or sourced from a dataset.
The primary outcome measure, as specified in the trial registration, was change in BDI-II score during the 4 weeks from baseline to posttreatment assessment.
In three cases the preset sample size and/or randomisation number were higher in the published reports than specified in the trial registry.
Similar(50)
Several group sequential statistical methods are available to adjust for multiple analyses, 129 130 131 and their use should be pre-specified in the trial protocol.
A further weakness is that these analyses were not pre-specified in the trial protocol with the attendant risk that random patterns in the data may have been over interpreted.
Investigation of QL as a predictor of treatment response or toxicity was not specified in the original trial protocols.
As these analyses were not specified in the original trial protocol and represent observational associations, the results must be interpreted with caution.
As extended RAS testing was not specified in this trial, the true number of patients with EGFR antibody-resistant tumors remains unknown.
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