“…The surveillance plan is reviewed annually and updated as necessary based on SAVY-4000 surveillance findings, as well as results of the lifetime extension studies. Four surveillance plan updates have been issued, one in 2014 (Kelly et al 2014), one in 2016 (Kelly et al 2016), one in 2017 (Kelly et al 2017) and one in 2018 (Kelly et al 2018). This 2019 update documents what was actually done in 2018 and what is planned for 2019.…”