Errata - AC statistical briefing document

 

 

  1. Page 6, Section 1.2 Analysis plan, 1st paragraph, line 6: change the text “an O.Brien-Fleming adjusting” to be “the Haybittle-Peto method” according to the corrections the sponsor provided for their original submission.

 

  1. Page 22, Section 3.1.1 Inflation of Type I error rate, 1st paragraph, line 1: change the text “June” to be “July” according to the corrections the sponsor provided for their original submission.

 

  1. Page 27, Section 3.2.2 P-value change or the primary efficacy endpoint, 1st paragraph, line 2: change the text “JUN” to be “July” according to the corrections the sponsor provided for their original submission.

 

  1. Page 27, Section 3.2.2 P-value change or the primary efficacy endpoint, 6th paragraph, line 1: change the text “June” to be “July” according to the corrections the sponsor provided for their original submission.