End of Study Definition. A participant is considered to have completed the study if he/she has completed all phases of the study including the last scheduled procedure shown in the Schedule of Activities (SoA). The end of the study is defined as the date the last participant completes the last visit shown in the SoA (Table 1).
End of Study Definition. The end of the study is defined as the date that the last subject completes both the Week 12 Visit and Week 14 Safety Follow-up Telephone Call Visit, discontinues from the study, or is lost to follow-up. A subject is considered to have completed the study if she completes 12 weeks of double-blind treatment at the Week 12 Visit.
