32 8.3.2 Clinical Laboratory Evaluations ............................................................................. 33 8.3.3 Vital Signs ............................................................................................................... 34 8.3.4 ECG ......................................................................................................................... 34 8.3.5 Physical Findings .................................................................................................... 34 8.3.6 Dosing and Extent of Exposure .............................................................................. 34 8.3.7 Prior and Concomitant Medications ....................................................................... 35 8.3.8 Analysis of Other Safety Variables ......................................................................... 35 9 CHANGES FROM THE PROTOCOL SPECIFIED STATISTICAL ANALYSES ........... 35 10 REFERENCES .....................................................................................................................