div class=ts-pagebuttonPage 1button div class=ts-image amp-img class=ts-thumb alt=Page 1: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails1jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 2button div class=ts-image amp-img class=ts-thumb alt=Page 2: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails2jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 3button div class=ts-image amp-img class=ts-thumb alt=Page 3: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails3jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 4button div class=ts-image amp-img class=ts-thumb alt=Page 4: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails4jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 5button div class=ts-image amp-img class=ts-thumb alt=Page 5: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails5jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 6button div class=ts-image amp-img class=ts-thumb alt=Page 6: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails6jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 7button div class=ts-image amp-img class=ts-thumb alt=Page 7: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails7jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 8button div class=ts-image amp-img class=ts-thumb alt=Page 8: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails8jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 9button div class=ts-image amp-img class=ts-thumb alt=Page 9: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails9jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 10button div class=ts-image amp-img class=ts-thumb alt=Page 10: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails10jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 11button div class=ts-image amp-img class=ts-thumb alt=Page 11: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails11jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 12button div class=ts-image amp-img class=ts-thumb alt=Page 12: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails12jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 13button div class=ts-image amp-img class=ts-thumb alt=Page 13: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails13jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 14button div class=ts-image amp-img class=ts-thumb alt=Page 14: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails14jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 15button div class=ts-image amp-img class=ts-thumb alt=Page 15: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails15jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 16button div class=ts-image amp-img class=ts-thumb alt=Page 16: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails16jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 17button div class=ts-image amp-img class=ts-thumb alt=Page 17: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails17jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 18button div class=ts-image amp-img class=ts-thumb alt=Page 18: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails18jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 19button div class=ts-image amp-img class=ts-thumb alt=Page 19: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails19jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 20button div class=ts-image amp-img class=ts-thumb alt=Page 20: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails20jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 21button div class=ts-image amp-img class=ts-thumb alt=Page 21: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails21jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 22button div class=ts-image amp-img class=ts-thumb alt=Page 22: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails22jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 23button div class=ts-image amp-img class=ts-thumb alt=Page 23: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails23jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 24button div class=ts-image amp-img class=ts-thumb alt=Page 24: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails24jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 25button div class=ts-image amp-img class=ts-thumb alt=Page 25: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails25jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 26button div class=ts-image amp-img class=ts-thumb alt=Page 26: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails26jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 27button div class=ts-image amp-img class=ts-thumb alt=Page 27: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails27jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 28button div class=ts-image amp-img class=ts-thumb alt=Page 28: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails28jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 29button div class=ts-image amp-img class=ts-thumb alt=Page 29: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails29jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 30button div class=ts-image amp-img class=ts-thumb alt=Page 30: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails30jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 31button div class=ts-image amp-img class=ts-thumb alt=Page 31: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails31jpg width=142 height=106 layout=responsive amp-img divdivdiv class=ts-pagebuttonPage 32button div class=ts-image amp-img class=ts-thumb alt=Page 32: Home - ClinicalTrialsgov · coefficient of variation CV% was estimated to be 255% by assuming m trasubject variability half of the total variability of 51% CDER 2003 Martin src=https:reader034vdocumentinreader034viewer20220424035f14f36cb862d171bf54ba67html5thumbnails32jpg width=142 height=106 layout=responsive amp-img divdiv