https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program https://www.merck.com/research-and-products/clinical-trials/ patients, instructions for use, packaging and patient education.