Ethics approval and consent to participate
The study protocol was approved by the Ethics Committee of the Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing (Reference number: BZYYYDX-LL-20150208). Signed ICFs were obtained from participants before they were assigned to the study groups. The study was conducted in accordance with the principles of the Declaration of Helsinki (2004) and in accordance with the Medical Research Involving Human Subjects Act (WMO). Note: the registration was supplemented later in the clinical trial registration center.