Written informed consent was obtained from all participants before they entered the study. The study protocol was approved by the local ethics committee (H-C-2008-103) and registered in ClinicalTrials.gov (no. NCT01027390).
Written informed consent was obtained from all participantsbefore they entered the study.The study protocol was approved by the local ethics committee(H-C-2008-103) and registered in ClinicalTrials.gov(no. NCT01027390).