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Supportive analyses by prominent law professors were read into the Congressional Record.
The robustness of the primary efficacy analysis was confirmed by supportive analyses, where significant between-group differences at day 43 were observed in MMRM analysis of the PP set (p = 0.005), MMRM modeling of the ITT set with robust variance estimates (p < 0.001), and ANCOVA modeling with LOCF methodology (p = 0.001).
Supportive analyses, based on the intention-to-treat cohort, counted all cases that emerged from the day of first vaccination.
Supportive analyses are planned in the per-protocol (PP) population.
The PP (perprotocol population) will be used for supportive analyses.
No evidence from supportive analyses conflicted with the primary analyses.
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We have conducted a thorough review of the manuscript and supportive study analyses from which it stems.
Supportive prespecified analyses were conducted in a modified-intention-to-treat (MITT) population that included all subjects who were naïve to the relevant HPV type(s) at enrolment and had received at least one vaccination.
In addition, we had supportive findings from analyses of our group (M.K).
Anchor-based and supportive distribution-based analyses produced a range of the potential values for the threshold for the responders and MID.
For two key endpoints, ACR50 response and DAS28 change, supportive post hoc analyses used propensity scores [ 11] computed using a logistic regression model (Electronic supplementary material (ESM) Table S1).
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