Analyzing intent-to-treat and per-protocol effects on safety outcomes using a medical information database: an application to the risk assessment of antibiotic-induced liver injury.
Yoshinori TakeuchiTomohiro ShinozakiHiraku KumamaruTatsuo HiramatsuYutaka MatsuyamaPublished in: Expert opinion on drug safety (2018)
Researchers should clearly define the target estimands, and carefully estimate and interpret both effects.