Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use
All specimens will be coded to the subject without personal identifiers and maintained in a repository by the investigators. The site principal investigator is responsible for maintaining accurate, complete, and up-to-date records for each subject and all specimens. The site principal investigator is also responsible for maintaining any source documentation for future use in epigenetic, immune functional studies, and other relevant analyses to provide insight into the impacts of treatment.