1 using the data sets, data dictionary, case report file, and statistical analysis plan from the original trial accessed th

2 he context of negative findings for the primary outcome and statistical analysis plan, this lower incidence was not consi

3 ing framework for study designs, sample size estimates, and statistical analysis plans for future pivotal trials of islet

4                       To ensure transparency, protocols and statistical analysis plans need to be published, and investig

5                          Trial registration, protocols, and statistical analysis plans are critically important in ensuri

6                         Following a prospectively developed statistical analysis plan, we reanalyzed safety data from eig

7  is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support transparency and

8                           Clinical trials need a predefined statistical analysis plan for uses of baseline data, especial

9 Blinded intention-to-treat analysis based on a prespecified statistical analysis plan included all participants eligible

10 h trial, we compared internal company documents (protocols, statistical analysis plans, and research reports, all unpubli

11 types of efficacy analyses were described in the protocols, statistical analysis plans, and publications, including ITT a

12                                                         The statistical analysis plan specified that if the between-group

13                                                         The statistical analysis plan was pre-specified in a protocol.

14 ped after an unplanned interim analysis of cohort 1 and the statistical analysis plan for the primary endpoint was amende

15      All analyses were prespecified in the protocol and the statistical analysis plan.

16 eduction in VAT were defined a priori as responders per the statistical analysis plan.