Ethics
The trials from which these data were gathered were performed in accordance with the principles of the Declaration of Helsinki and the International Council for Harmonization Good Clinical Practice guidelines. Each site had approval from a local institutional ethics review board or ethics committee, and appropriate written informed consent was obtained for each participant. Data were collected by clinical investigators and analyzed by AstraZeneca. Neither the investigators nor the parents or guardians were aware of the trial group assignments, and all authors had access to the results of the aggregated analysis. The authors reviewed the manuscript, made the decision to submit the manuscript for publication, and vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol. AstraZeneca was involved in the trial design; the collection, analysis, and interpretation of the data; and the writing of the manuscript.