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The primary analysis (for both STEP 1 and STEP 2) will be intention-to-treat.ISRCTN10248064.
Data collection and primary analysis for NMR and XRD were done by the embedded software of the instruments as described above.
The primary analysis for primary and secondary outcomes will be based on an Intention-To-Treat (ITT) analysis comprise all study participants completed the baseline measurements.
The primary analysis for this study has already been conducted [4].
We estimated the number of participants needed to reject the null hypothesis (no difference between valerian and placebo) for the primary analysis for proportions from 0.15 to 0.40 in the placebo group and absolute improvements of 10 to 25% based on Pearson Chi-square 2-sided tests for two proportions, with a significance level of 0.05 and 80% power.
The primary analysis for immunogenicity was conducted on the ATP cohort for immunogenicity, defined as all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
The primary analysis for efficacy was conducted on the ATP cohort for efficacy defined as all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy endpoint measures were available.
So we do not stratify our primary analysis for center.
Outlier analysis did not change the inference of the primary analysis for HK.
IHC will be used for primary analysis for which sample size estimation was performed.
The primary analysis for secondary outcome will be the adjusted analysis.
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