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While best developed for randomized, controlled trials, guidelines for other study types are being developed.
Based on the cardiovascular risks of pre-approval clinical trials, guidelines have been made to conduct cardiovascular safety outcome trials (CVSOTs) prior to the drug approval or after the drug has been approved.
Reporting of results should follow the Consolidated Standards for Reporting Trials guidelines and include secondary outcome measures to support or explain the primary outcome and an analysis of harms data.
Reporting of results should follow the Consolidated Standards for Reporting Trials guidelines and include an analysis of harms data and secondary outcome measures to support or explain the primary outcome.
Finally, few studies employed blinded controls (e.g., sham CBT) making it hard to understand the true placebo effect of receiving what may be perceived as 'high tech treatment.' However, per the Behavioral Clinical Headache Trials Guidelines, the placebo is not a realistic expectation of behavioral trials anyway [40].
In accordance with the Consolidated Standards of Reporting Trials guidelines [31], we relied on interactions between treatment and subgroups with the aim to avoid misinterpretation and to better understand the trial results for subgroups of patients.
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We describe the CTN trial here by adopting the Consolidated Standards of Reporting Trials guideline.
Based on the current landscape of clinical trials, guideline recommendations remain inconclusive.
The trial followed the consolidated standards of reporting trials guideline extended for cluster-randomised controlled trials [ 34].
The results from this trial will be reported at the completion of the study in accordance with the Consolidation of Standards for Reporting Trials guideline [ 24].
Such studies should follow clinical trial guidelines from the International Headache Society [21, 22].
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