Summary of criteria used for including participants in seven types of analyses for efficacy as described in protocols, statistical analysis plans, and publications across the nine included trials.

aThis table summarizes data presented in Tables 4 and 5 and Text S1's table 1. Along the top row in this table, we show every type of efficacy analysis described in the protocols, SAPs, and publications across all nine trials for which we compared these documents. The first column on the left lists the criteria used to define the types of analysis across all studies. For each type of analysis, an “X” denotes that the criterion was applied in at least one of the documents for any of the nine trials we examined. For example, the second column summarizes the five criteria used across all documents and trials to define ITT: in Table 4, four criteria were used in different combinations to define ITT analysis; in Text S1's table 1, one additional criterion was used in the SAP.bThis type of analysis was specified protocols, SAPs, and publications for the trials we examined (Tables 4 and 5 and Text S1's table 1).cThis type of analysis was specified only in the protocol and publications for some of the trials we examined (see Table 5).dThis type of analysis specified only in SAPs for some of the trials we examined (see Text S1's table 1).CGIS, clinical global impression of severity; HAM-D, Hamilton Depression Rating Scale; YMRS, Young Mania Rating Scale.