We thank Maldonado et al and Dunne et al for their interest in our article. Although Maldonado et al at Johnson & Johnson discuss that “only” 11% of the trials we evaluated were conducted solely outside the United States, representing a small proportion of studies, it should be noted that most (65%) of the trials enrolled patients in at least 1 country outside of the United States. We appreciate that Johnson & Johnson has policies regarding site selection, transparency, and publication. However, policies such as theirs do not seem to be in place across the board; we have previously shown that fewer than half of the studies conducted under the pediatric exclusivity provision were published in the peer-reviewed literature. In addition, in our study we found that 9% of the published studies did not report any information regarding the location or number of sites in which the...

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