Study oversight
ADVERSE EVENTS
This trial was approved by an ethics committee at each study site and was conducted in accordance with Good Clinical Practice guidelines and the World Medical Association Declaration of Helsinki. Written informed consent was provided by the patient or by parents/caregivers. The sponsor, F. Hoffmann-La Roche Ltd, provided the study drug, study management and medical monitoring, drug safety management and analysis, data management and statistical analysis, and pharmacokinetic/pharmacodynamic analysis. Confidentiality agreements were in place between the authors and F. Hoffmann-La Roche Ltd. An external independent data monitoring committee monitored the safety of patients. All authors attest to adherence to the protocol, accuracy of analysis, and complete reporting of adverse events (AEs).