Common use of Monitoring of Adverse Events and Period of Observation Clause in Contracts

Monitoring of Adverse Events and Period of Observation. All AEs will be monitored until they are resolved or have become chronic or stable. AEs and SAEs will be recorded on the case report forms starting from the time of subject entry from Day 1 of the study until the final study visit (Month 24). Any SAEs that occur at any time after completion of the study, which the Investigator considers to be related to study drug, must be reported to the Sponsor or its designee.

Monitoring of Adverse Events and Period of Observation. All AEs will be monitored until they are resolved or have become chronic or stable. AEs and SAEs will be recorded on the case report forms starting from the time of subject patient entry from Day 1 into the Pretreatment Period (Visit 2) of the study until 30 days after the final last dose of study visit (Month 24)medication. SAEs will be collected up to 30 days after the last dose of study medication. Any SAEs that occur at any time after completion of the study, which the Investigator considers to be related to study drug, must be reported to the Sponsor or its designee.