8.3           Assessment of Dropouts .................................................................................

25

                8.3.1        Overall Pattern of Dropouts .............................................................

25

                8.3.2        Adverse Events Associated with Dropout ........................................

26

8.4           Safety Findings Discovered with Other Specific Search Strategies ...............

28

8.5           Other Safety Findings .....................................................................................

29

                8.5.1        ADE Incidence Tables .....................................................................

29

                8.5.2        Laboratory Findings .........................................................................

32

                8.5.3        Vital Signs and Weight ....................................................................

37

                8.5.4        Electrocardiograms ..........................................................................

38

                8.5.5        Special Studies .................................................................................

38

                8.5.6        Withdrawal Phenomena/Abuse Potential .........................................

40

                8.5.7        Human Reproduction Data ...............................................................

40

                8.5.8        Overdose Experience .......................................................................

40

8.6           Summary of Important Adverse Events Considered Drug Related ................

41

8.7           Summary of Other Important Adverse Events Considered Not Drug Related ..

42

8.8           Summary of Drug Interactions ...........................................................................

43

                8.8.1        Drug-Demographic Interactions ..........................................................

43

                8.8.2        Drug-Disease Interactions ....................................................................

43

                8.8.3        Drug-Drug Interactions ........................................................................

43

9.0

Labeling Review ...............................................................................................................

44

10.0

Conclusions ......................................................................................................................

44

11.0

Recommendations ............................................................................................................

44