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23/11/2004

30/11/2004

FIGURE 2 Disposition of subjects.

Each subject was examined thoroughly during screening procedures as described in the study protocol (the screening time being set to be between 1 month and 24 hours prior to the first study drug administration of study period I). Twenty-four subjects plus four alternates were enrolled and completed the study period II (Fig. 2).

4.2. Withdrawals and Exclusions

During this study, 39 subjects were screened. Two subjects withdrew for significant variation of their lab results, 11 subjects withdrew for personal reasons and two subjects withdrew for protocol violation. A total of 28 subjects were enrolled in period I and have completed both periods of the study. For details on withdrawals, see Appendix B.1.

4.3. Demographic Characteristics

The demographic characteristics of the 24 subjects, who completed the study and included in the pharmacokinetic analysis, were as follows:

■ Age ranging between 18 and 36 years (26+ 4.96 years).

■ Weight at screening examination between 56 and 87 kg (70 + 8.84 kg).

For detailed information about the demographic data obtained for the 28 volunteers at screening examination, see Appendix B.3.

4.4. Variations from the Study Protocol

Slight variations from the study protocol concerning the clinical laboratory tests were observed (a list of these variations is found in Appendix B.2. "Impact of the Variations from the Study Protocol on the Study Outcome"). These variations were judged by the Principal Investigator to be insignificant.

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