Total number of participants randomized and number analyzed for efficacy per research report and publication for the publication-specified primary outcome.

aThe only published report available to us for study 879-201, which we used as its “main publication,” was a conference abstract describing preliminary results of analyses from the trial [27]. The only published report available to us for the study, No ID Gorson, which we used as its “main publication,” was a letter to the editor describing results from the trial [22]. We did not use a conference abstract, a report describing preliminary results of analyses, or a letter to the editor as the “main publication” for any other trial listed in this table.bWe could not compare the internal company research report and publication because the internal company research report did not report on the publication-specified primary outcome.cThe numbers presented are for Young Mania Rating Scale, which was one of two outcomes considered “primary.” The corresponding numbers for the other outcome considered “primary,” the Hamilton Depression Rating Scale (HAM-D) are as follows: ITT: 113 in the research report and 113 in publication.dWe could not compare the internal company document and publication because the internal company research report did not specify the type of analysis specified in the publication, even though the outcomes were the same.eA draft manuscript sent to Pfizer and Parke-Davis by the author reports a total of 53 patients were allocated in the trial and 40 participants were analyzed for efficacy.