Gynaecological Follow-up of a Subset of 580299/008 (NCT 00122681) Study Subjects

Inclusion Criteria:

- Written informed consent obtained from the subject prior to enrolment.

- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol should be enrolled in the study.

- A subject previously enrolled in the study NCT 00122681 and who fulfils either of the
following criteria:

- displayed normal cervical cytology but tested positive for oncogenic HPV infection at
her last NCT 00122681 study visit (Visit 10, Month 48).

or

• was pregnant at her last visit of the NCT 00122681 study (Visit 10, Month 48) so that no
cervical sample could be collected at that visit.

Exclusion Criteria:

- A subject who displayed normal cervical cytology and who was negative for oncogenic
HPV infection at her last NCT 00122681 study visit (Visit 10, Month 48).

- A subject who had a cervical lesion at her last NCT 00122681 study visit (Visit 10,
Month 48) or who had a cervical lesion that required treatment at the NCT 00122681
exit colposcopy.

- A subject for whom the cervical cytology results from the last NCT 00122681 study
visit (Visit 10, Month 48) were unavailable for reasons other than pregnancy.

If at the time of enrolment the subject experiences heavy bleeding (menstruation or other)
or heavy vaginal discharge, or is pregnant, the pelvic exam cannot be performed. The
subject's first study visit will be deferred until condition is resolved according to
investigator's medical judgment.