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In this article, we discuss the objectives and trial designs that have enabled the public-private partnerships required to complete the scale of both trials, as well as interim trial updates and strategic considerations that have driven data analysis and targeted therapy assignment, with the intent of elucidating further the benefits of this treatment approach for patients.
Definition of these relationships may inform future clinical trial design and interpretation of interim trial data.
Interim trial results suggested that the vaccine could have a high level of efficacy in humans (3 ).
However, in Figures 2 and 3, Tosh et al use ranges of 0 to 16 to describe explanatory trials and 16 to 35 to describe an interim trial that is balanced.
The DMC will consider any requests for release of interim trial data and to recommend to the TSC on the availability of this and in the event of further funding being required, to provide to the TSC and MRC appropriate information and advice on the data gathered to date that will not jeopardise the integrity of the study.
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In the interim, all trials should report the proportions of participants with complete clearance of symptoms.
We classified the publication status of completed or discontinued trials as "published" if a full-text paper on final study results (completed trials) or interim results (discontinued trials) was identified in the literature search, and "unpublished" if this was not the case.
† Published/unpublished: full-text publications of final results (completed trials) or interim results (discontinued trials) were available/not available.
An RCT was classified as "unpublished" if no full-text paper on final study results (completed trials) or interim results (discontinued trials) was available.
The publication status of completed or discontinued RCTs was classified as "published" if a full-text paper on final study results (completed trials) or interim results (discontinued trials) was available, and "unpublished" if this was not the case.
In contrast to these two trials, interim analysis from the AZURE trial did not show a benefit from adding ZOL to adjuvant therapy in the overall patient population [ 4].
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