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Outcomes are assessed masked to treatment assignment at 3 months (main trial endpoint) and 6 months (maintenance effects).
The upper boundaries of the 2-sided 95% CI for the risk differences estimated between SP-IPTp and the IST groups were below the non-inferiority margin of 5% for third trimester severe anaemia, the main trial endpoint (Figure 3A).
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We propose to conduct a single analysis of main trial endpoints at the end of the study.
Using the 3-month endpoint in the pilot study and a lower significance level would cause us to proceed to the main trial after the pilot study only to observe no significant difference between the two groups in the main study.
This outcome was not a pre-specified trial endpoint.
Clinical trials, however, have become a major challenge because of issues with trial endpoints.
The trial endpoints, reached at 3 and at 6 months, have previously been reported [8].
Nevertheless, all vaccines tested to date have failed to meet clinical trial endpoints.
FIS will facilitate the identification of meaningful functional goals and interpretable clinical trial endpoints.
This can be especially important if trial endpoints are then used to estimate final economic endpoints.
The suggested efficacy of anti-angiogenic drugs in patients with recurrent GBM is based on non-randomised trials with PFS as the main study endpoint.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com