Comparison of protocol (Pro), SAPs, and publications (Pub) for description of criteria used to determine inclusion of trial participants in safety analysis.

aNeither the protocol, SAP, nor the publication for Study 879-201 described criteria used to determine inclusion of trial participants in safety analysis.bNeither the protocol nor the publication for Study No ID - Gorson described criteria used to determine inclusion of trial participants in safety analysis.c“All patients who have taken study medication will be included in the evaluation of safety data.”d“Any patient who has taken at least one dose of study medication and has had an opportunity to report an adverse experience via clinic visit, telephone contact, etc. will be evaluable for the safety analysis.”