Quality of Reporting of Generic Drug Trials Figure 1. Flow diagram of the selection of reports of trials comparing generic to brand-name drugs published between 2005 and 2008. doi:10.1371/journal.pone.0023611.g001 that they had increased the number of participants during the study because they could not conclude bioequivalence with the initial sample size. The method used to generate the randomization sequence was reported and adequate in 12 articles (15%). Allocation conceal- ment was reported and adequate in 4 articles (5%). Blinding of study participants, care providers and outcome assessors was reported in 13 (16%), 11 (14%) and 6 (8%) articles, respectively. In total, 38 articles (48%) reported that data for all participants were included in the analysis and 18 (23%) that some participants were excluded from analysis; the remaining 23 (29%) gave no information on potential exclusion. The statistical analysis test was reported in 73 articles (94%) and was ANOVA for 67 articles (86%) and t test for 6 (8%). Six articles (6%) did not report which test was used. For the 67 articles reporting ANOVA, 78% described taking into account period, 73% sequence, 66% formulation and 66% subject within sequence. Setting and population characteristics As shown in Table S3, the location of the study was reported in 44 articles (56%). Of these, 22 (50%) studies were performed in Asia. In total, 73 articles (92%) described the inclusion of exclusively healthy participants. Six articles about NTI drugs (38%) described the inclusion of non-healthy participants. The age of participants was reported in 62 articles (78%), and the median age was 28 years (IQR 23 to 33). Exclusion criteria were reported PLoS ONE | www.plosone.org 3 August 2011 | Volume 6 | Issue 8 | e23611