Group: Common

Site number Must be an integer.

Subject ID

Visit Date Sunday February 18, 2007 Must be a valid date. Correct format is: yyyy-mm-dd

Visit Start Time Must be a valid time. Correct format is: hh:mm:ss

Group: Adverse events

Has the subject experienced any adverse events No Yes

Group: Adverse events

Event No. Must be an integer.Value must be lower than 1000

Adverse event enter text

Start Date Sunday February 18, 2007 Must be a valid date. Correct format is: yyyy-mm-dd

Is the adverse event still continuing No Yes

Stop Date Sunday February 18, 2007 Must be a valid date. Correct format is: yyyy-mm-dd

Duration of the adverse event Must be a valid duration. Correct format is: PnYnMnDTnHnMnS

Was event serious No Yes

Severity Mild Moderate Severe

Is there a reasonable possibility that the AE may have been caused by the study drug No Yes

Action taken with study drug None Study drug regimen changed Temporarily stopped study drug Study drug discontinued

Subject outcome Subject remains in study Withdrawn from study Lost to follow-up Death