Regulations.gov document: Reference 12 - FDA, International Council for Harmonisation (ICH) guidance for industry ‘‘E9 Statistical Principles for Clinical Trials,’’ (September 1998),
available at https://www.fda.gov/media/71336/download (accessed Apr. 24, 2026). — retained record — High Signal
Regulations.gov document: Reference 12 - FDA, International Council for Harmonisation (ICH) guidance for industry ‘‘E9 Statistical Principles for Clinical Trials,’’ (September 1998),
available at https://www.fda.gov/media/71336/download (accessed Apr. 24, 2026).