2.3 Collection, recording and reporting of adverse events
All safety data were assessed by the treating physician. Standard definitions were used for adverse event, seriousness, and outcome. Relatedness was defined as either ‘’Possible”: a causal relationship is conceivable and at least reasonably possible; or ‘’Unlikely”: the event is most likely related to a different etiology than the medicinal product. AEs with unclear causality were categorized as possibly related. Safety data solicited were all serious adverse events (SAE), all causal AEs, and AEs of special interest. Any unsolicited safety data reported by physicians were also included. All AEs reported were categorized by preferred term and system organ class (Medical Dictionary for Regulatory Activities versions 23.0).