CPMP fandt, at eventuelle bias, der er fundet i Medicinska födelseregistret, herunder misklassifikation, ville give risikoestimatet en bias i retning mod 1 eller være uden indflydelse.
The CPMP considered that possible biases that have been identified in the SMBR, including misclassifications, would bias the risk estimate towards 1 or not affect it.