The analyses described here are those necessary to answer the trial’s primary question of whether combined treatment with vitamin C, thiamine and steroids is more effective than placebo in increasing days alive and free from respiratory and vasopressor support and reducing mortality in patients with sepsis.

Beyond our analysis exploring the effect of treatment on primary, secondary, and exploratory endpoints, we expect there to be multiple additional exploratory analyses conducted.

It is not possible to predetermine the nature of such analyses, particularly as a rich biospecimen repository is being developed as a component of this study.

However, we are committed to preserving rigor and reproducibility and will prespecify each subsequent analysis in the context of the specific question to be answered, cognizant of bias and missingness in the data.

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