ICH website, ICH E8(R1) Harmonised guideline General Considerations for Clinical Studies, https://database.ich.org/sites/default/files/E8-R1_Guideline_Step4_2021_1006.pdf
ICH website, ICH E8(R1) Harmonised guideline General Considerations for Clinical Studies, https://database.ich.org/sites/default/files/E8-R1_Guideline_Step4_2021_1006.pdf