UMIN-CTR Clinical Trial Number : UMIN000006982 ; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000008238&language=E ( Archived by WebCite at http://www.webcitation.org/6MRPQeEAv ) .