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It was reported in this paper that “Informed consent was obtained from all patients and/or their parents and the Ethics Committee of the National Cardiovascular Centre approved the study protocol”.
The study was approved in advance by our institutional ethics committee (National Cerebral and Cardiovascular Centre, Suita, Japan; approval number M23-002; received 18 April 2011) on the understanding that it would be performed under the ethical guidelines for clinical studies.
It was believed that an opt-out policy was in place for patients that were approached to participate in this study. However, it became apparent later that the appropriate information about this study had not been posted online and patients were not in fact offered the right to refuse participation.
Our institutional ethics committee considered this error to be…