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The framework is intended to maximize efficiency and minimize confusion in the implementation of QTLs. The framework includes proposed approaches for implementation of QTLs for a clinical trial as defined in Section 5.0.4 and 5.0.7 of ICH E6(R2) (International Council for Harmonisation (ICH). ICH harmonised guideline integrated addendum to ICH E6(R1) guideline for good clinical practice E6(R2). 2016. https//database.ich.org/sites/default/files/E6_R2_Addendum.pdf . Accessed 5 Dec 2019) and considerations for setting thresholds. Polyphar
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