ASPIrin in Reducing Events in Dialysis ( ASPIRED )

NCT ID: NCT04381143

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

9000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-30

Study Completion Date

2026-12-31

Brief Summary

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People with kidney failure requiring dialysis have a much higher risk of developing cardiovascular (CV) disease compared with the general population. A cardiac cause accounts for 58% of all deaths in patients with end stage kidney disease (ESKD). At the same time, this population has increased risks of clotting as well as bleeding episodes. While aspirin is known to reduce cardiovascular complications in the general population, evidence to support the use of aspirin in people with ESKD receiving dialysis therapy is currently lacking. The ASPIrin to Reduce Event in Dialysis (ASPIRED) trial will test whether aspirin use in dialysis patients safely improves outcomes compared with no aspirin use.

Detailed Description

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ASPIRED is an investigator-initiated, multi-center, double-blind, parallel group, event-driven, pragmatic, registry-based randomized controlled trial that will define the value of low dose aspirin (100 mg daily) on cardiovascular events in people with ESKD receiving dialysis.

The study will be conducted using the existing platform of the Chinese peritoneal dialysis (PD) and hemodialysis (HD) Dialysis Registry to screen, recruit and to collect study data as part of patient's routine clinical care during dialysis to improve efficiency and to minimize cost of a clinical trial.

ASPIRED is an event driven trial with an anticipated duration of approximately 5 years.

Randomization will be performed using a web-based system via a pass word protected encrypted website interface.

The study procedure utilizes routine six-monthly clinic visits for study follow-up to increase efficiency and minimize the burden on participants.

The analysis will be based on intention-to-treat principles. An independent Data Safety and Monitoring Board (DSMB) will established to monitor the study for safety and efficacy.

Conditions

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CKD (Chronic Kidney Disease) Stage 5D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic designs
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aspirin

Aspirin tablet 100mg daily

Group Type ACTIVE_COMPARATOR

Aspirin 100 mg Oral Tablet

Intervention Type DRUG

Aspirin 100 mg tablet daily

Matching Placebo

Placebo tablet 1 pill daily

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Matching Placebo 1 pill daily

Interventions

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Aspirin 100 mg Oral Tablet

Aspirin 100 mg tablet daily

Intervention Type DRUG

Matching Placebo

Matching Placebo 1 pill daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Incident or prevalent adults (≥18 years old) dialysis patients are included in the Dialysis Registry.
* Commenced on dialysis with the expectation of ongoing maintenance dialysis requirement.
* Willing and able to provide informed consent for this study.

Exclusion Criteria

* Requirement for any form of antiplatelet agent (aspirin, glycoprotein IIb/IIIa inhibitors etc), or oral anticoagulation (warfarin, NOACs), in the view of the treating physician.
* Contraindication to aspirin, in the view of the treating physician.
* Dialysis requirement due to acute kidney injure with expectation of kidney function recovery.
* History of haemorrhagic stroke or intracranial bleed within 12 months of screening.
* Coagulopathy from any cause.
* Unable to provide informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The George Institute

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xueqing Yu

Role: STUDY_CHAIR

Guangdong Provincial People's Hospital

Vlado Perkovic

Role: STUDY_CHAIR

The University of New South Wales Sydney

Muh Geot Wong

Role: STUDY_DIRECTOR

The George Institute

Wei Chen

Role: STUDY_DIRECTOR

First Affiliated Hospital, Sun Yat-Sen University

Li Fan

Role: STUDY_DIRECTOR

Guangdong Provincial People's Hospital

Zhiming Ye

Role: STUDY_DIRECTOR

Guangdong Provincial People's Hospital

Locations

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The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

Shanghang County Hospital

Longyan, Fujian, China

Site Status RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Site Status RECRUITING

Dongguan Donghua Hospital

Dongguan, Guangdong, China

Site Status RECRUITING

Dongguan Hospital of Integrative Traditional Chinese and Western Medicine

Dongguan, Guangdong, China

Site Status NOT_YET_RECRUITING

Dongguan Houjie Hospital

Dongguan, Guangdong, China

Site Status NOT_YET_RECRUITING

Dongguan Eighth People's Hospital

Dongguan, Guangdong, China

Site Status RECRUITING

Dongguan Marina Bay Center Hospital

Dongguan, Guangdong, China

Site Status RECRUITING

Dongguan People's Hospital

Dongguan, Guangdong, China

Site Status RECRUITING

Dongguan Songshan Lake Center Hospital

Dongguan, Guangdong, China

Site Status WITHDRAWN

Lufeng People's Hospital

Donghai, Guangdong, China

Site Status WITHDRAWN

Foshan Gaoming District People's Hospital

Foshan, Guangdong, China

Site Status RECRUITING

The Second People Hospital of Foshan Nanhai

Foshan, Guangdong, China

Site Status RECRUITING

Foshan Nanhai District People's Hospital

Foshan, Guangdong, China

Site Status RECRUITING

Foshan No.1 people's hospital

Foshan, Guangdong, China

Site Status RECRUITING

Foshan Sanshui People's Hospital

Foshan, Guangdong, China

Site Status RECRUITING

Foshan Second People's Hospital

Foshan, Guangdong, China

Site Status RECRUITING

Guangdong Provincial Hospital of Integrative Medicine

Foshan, Guangdong, China

Site Status RECRUITING

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Guangdong Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Guangzhou Redcross Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Guangdong Provincial Hospital of Traditional Chinese Medicine Fangcun Branch (Guangzhou Charity Hospital)

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Site Status RECRUITING

The Fifth Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Guangdong Agricultural Reclamation Central Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Guangdong Cliffod Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Hua Du District People's Hospital of Guangzhou

Guangzhou, Guangdong, China

Site Status RECRUITING

Panyu District people's hospital of Guangzhou

Guangzhou, Guangdong, China

Site Status RECRUITING

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Site Status RECRUITING

The Sixth Affiliated Hospital of Sun yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guanzhou, Guangdong, China

Site Status RECRUITING

Heyuan People's Hospital

Heyuan, Guangdong, China

Site Status RECRUITING

Huizhou First People Hospital

Huizhou, Guangdong, China

Site Status RECRUITING

Huizhou Central People's Hospital

Huizhou, Guangdong, China

Site Status RECRUITING

The People's Hospital of Jiangmen

Jiangmen, Guangdong, China

Site Status RECRUITING

Jiangmen Center hospital

Jiangmen, Guangdong, China

Site Status RECRUITING

Jieyang People's Hospital

Jieyang, Guangdong, China

Site Status RECRUITING

Kaiping Center Hospital

Kaiping, Guangdong, China

Site Status RECRUITING

Lianjiang People's Hospital

Lianjiang, Guangdong, China

Site Status RECRUITING

Lianping County People's Hospital

Lianping, Guangdong, China

Site Status NOT_YET_RECRUITING

The Fourth Affiliated Hospital of Guangzhou Medical University

Licheng, Guangdong, China

Site Status RECRUITING

Maoming Hospital of Traditional Chinese Medicine

Maoming, Guangdong, China

Site Status RECRUITING

Maoming People's Hospital

Maoming, Guangdong, China

Site Status RECRUITING

Meizhou People's Hospital

Meizhou, Guangdong, China

Site Status RECRUITING

The Third Affiliated Hospital of Sun Yat-sen University Yuedong Hospital

Meizhou, Guangdong, China

Site Status RECRUITING

Puning People's Hospital

Puning, Guangdong, China

Site Status RECRUITING

Qingyuan People's Hospital

Qingyuan, Guangdong, China

Site Status RECRUITING

Fogang People Hospital

Qingyuan, Guangdong, China

Site Status RECRUITING

Qingyuan Hospital of Traditional Chinese Medicine

Qingyuan, Guangdong, China

Site Status RECRUITING

The Second Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Site Status WITHDRAWN

The first Affiliated Hospital of Shantou Medical University

Shantou, Guangdong, China

Site Status RECRUITING

Shantou Chaonan Minsheng Hospital

Shantou, Guangdong, China

Site Status RECRUITING

Shanwei People's Hospital

Shanwei, Guangdong, China

Site Status RECRUITING

Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University

Shanwei, Guangdong, China

Site Status RECRUITING

Wengyuan People Hospital

Shaoguan, Guangdong, China

Site Status RECRUITING

Shaoguan First People's Hospital

Shaoguan, Guangdong, China

Site Status RECRUITING

The First People's Hospital of Shaoguan

Shaoguan, Guangdong, China

Site Status RECRUITING

Yuebei People's Hospital

Shaoguan, Guangdong, China

Site Status RECRUITING

The Seventh Affiliated Hospital of Sun Yat-sen

Shenzhen, Guangdong, China

Site Status RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Shenzhen Baoan People's Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, China

Site Status RECRUITING

Shenzhen Longhua District People's Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Shenzhen No.2 people's hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

The Eighth Affiliated Hospital of Sun Yat-sen University (Futian, Shenzhen)

Shenzhen, Guangdong, China

Site Status RECRUITING

ShunDe Hospital Guangzhou University of Chinese Medicine

Shunde, Guangdong, China

Site Status RECRUITING

The Eighth Affiliated Hospital of Southern Medical University, The First People's Hospital of Shunde

Shunde, Guangdong, China

Site Status RECRUITING

Nanxiong People Hospital

Xiongzhou, Guangdong, China

Site Status RECRUITING

People's Hospital of Yangdong District Yangjiang City

Yangjiang, Guangdong, China

Site Status RECRUITING

Yangjiang Hospital of Traditional Chinese Medicine

Yangjiang, Guangdong, China

Site Status RECRUITING

Yangjiang People's Hospital

Yangjiang, Guangdong, China

Site Status RECRUITING

People Hospital of Yingde City Guangdong Province

Yingcheng, Guangdong, China

Site Status RECRUITING

Yunfu People's Hospital

Yunfu, Guangdong, China

Site Status RECRUITING

The Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Site Status RECRUITING

Central People's Hospital of Zhanjiang

Zhanjiang, Guangdong, China

Site Status RECRUITING

The Third Affiliated Hospital of Sun Yat-sen University Zhaoqing Hospital

Zhaoqing, Guangdong, China

Site Status NOT_YET_RECRUITING

Zhaoqing first people's hospital

Zhaoqing, Guangdong, China

Site Status RECRUITING

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

Site Status RECRUITING

Zhongshan Traditional Chinese Hospital

Zhongshan, Guangdong, China

Site Status WITHDRAWN

Zhongshan Xiaolan People's Hospital

Zhongshan, Guangdong, China

Site Status RECRUITING

Jinwan Center Hospital of Zhuhai

Zhuhai, Guangdong, China

Site Status RECRUITING

The fifth affiliated hospital of sun yat-sen university

Zhuhai, Guangdong, China

Site Status RECRUITING

Zhuhai People's Hospital

Zhuhai, Guangdong, China

Site Status RECRUITING

Shantou Central Hospital

Shantou, Guanggong, China

Site Status RECRUITING

The Affiliated Hospital of Youjiang Ethnic Medicine College

Baise City, Guangxi, China

Site Status RECRUITING

The first affiliated hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status RECRUITING

Anshun Xixiu District People's Hispital

Anshun, Guizhou, China

Site Status NOT_YET_RECRUITING

China Guihang 302 Hospital

Anshun, Guizhou, China

Site Status RECRUITING

Anshun People Hospital

Anshun, Guizhou, China

Site Status RECRUITING

Guizhou Province Peple's Hospital

Guiyang, Guizhou, China

Site Status WITHDRAWN

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Site Status NOT_YET_RECRUITING

Hainan Provincial People's Hospital

Haikou, Hainan, China

Site Status RECRUITING

Xinyang Central Hospital

Xinyang, Henan, China

Site Status RECRUITING

Huangshi Central Hospital

Huangshi, Hubei, China

Site Status NOT_YET_RECRUITING

Jingmen Central Hospital

Jingmen, Hubei, China

Site Status NOT_YET_RECRUITING

Jingzhou Central Hospital

Jingzhou, Hubei, China

Site Status NOT_YET_RECRUITING

Wuhan Puren Hospital

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

The First People's Hospital of Jiangxia District, Wuhan City

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

The Central Hospital of Wuhan

Wuhan, Hubei, China

Site Status RECRUITING

The Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Tongji Hospital, Tongji Medical College of Huazhong Science and Technology University

Wuhan, Hubei, China

Site Status RECRUITING

Wuhan No.1 People's Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Yichang central people's hospital

Wuhan, Hubei, China

Site Status WITHDRAWN

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status WITHDRAWN

Xiangyang Central Hospital

Xiangyang, Hubei, China

Site Status RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, China

Site Status RECRUITING

The third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, China

Site Status RECRUITING

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Site Status WITHDRAWN

Nantong Haimen People's Hospital

Nantong, Jiangsu, China

Site Status RECRUITING

Xuzhou Mining Group General Hospital

Xuzhou, Jiangsu, China

Site Status NOT_YET_RECRUITING

Subei People's Hospital

Yangzhou, Jiangsu, China

Site Status RECRUITING

Ganzhou Municiple Hospital

Ganzhou, Jiangxi, China

Site Status RECRUITING

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

Site Status RECRUITING

Jiujiang No.1people's Hospital

Jiujiang, Jiangxi, China

Site Status RECRUITING

Jiangxi Province Peple's Hospital

Nanchang, Jiangxi, China

Site Status RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status WITHDRAWN

The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)

Xi’an, Shanxi, China

Site Status RECRUITING

The First Affiliated Hospital of Air Force Military Medical University

Xi’an, Shanxi, China

Site Status WITHDRAWN

Sichuan Province People's Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Jiashi County People's Hospital

Kashgar, Xinjiang, China

Site Status RECRUITING

Shache County People's Hospital

Kashgar, Xinjiang, China

Site Status RECRUITING

The First People's Hospital of Kashi Prefecture

Kashgar, Xinjiang, China

Site Status RECRUITING

The Second People's Hospital of Kashi Prefecture

Kashgar, Xinjiang, China

Site Status RECRUITING

The First Affiliated Hospital of Shihezi University Medical College

Shihezi, Xinjiang, China

Site Status RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status WITHDRAWN

The People's hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

Site Status WITHDRAWN

Fengqing People's Hospital of Yunnan Province

Lincang, Yunnan, China

Site Status RECRUITING

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Lishui City Center Hospital

Lishui, Zhejiang, China

Site Status NOT_YET_RECRUITING

Zhoushan Hospital

Zhoushan, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xueqing Yu

Role: CONTACT

+86-20-83827812

Li Fan

Role: CONTACT

+86-20-87755766-8174

Facility Contacts

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Jianxin Wan

Role: primary

Jianzhong Su

Role: primary

Tianxi Liu

Role: primary

Xiaoyan Su

Role: primary

Huan Lu

Role: primary

Changchang Xiao

Role: primary

Zhixiong Lin

Role: primary

Houqin Xiao

Role: primary

Guohui Liu

Role: primary

Tao Feng

Role: primary

Xia Jiang

Role: primary

Fuzhang Luo

Role: primary

Yaozhong Kong

Role: primary

Sinian Chen

Role: primary

Bo Zhang

Role: primary

Min Zhang

Role: primary

Ying Tang

Role: primary

Huafeng Liu

Role: primary

Qiongqiong Yang

Role: primary

Yan Liu

Role: primary

Haibo Long

Role: primary

Youguang Liu

Role: backup

Lixin Wang

Role: primary

Panna Liu

Role: primary

Huixin Bi

Role: primary

Jiping Wang

Role: primary

Yanchun Wang

Role: primary

Xueqing Yu

Role: primary

Shuguang Qin

Role: primary

Yunfang Zhang

Role: primary

Minyan Xie

Role: primary

Jie Xiao

Role: primary

Gangyi Chen

Role: primary

Zongpei Jiang

Role: primary

Hui Peng

Role: primary

Jianteng Xie

Role: primary

Yanbo Teng

Role: primary

Yongjun Shi

Role: primary

Danhong Yu

Role: primary

Qingdong Xu

Role: primary

Qinhua Liu

Role: primary

Wei Chen

Role: primary

Weipeng Huang

Role: primary

Jumei Xia

Role: primary

Chaohui Wen

Role: primary

Yeming Lu

Role: primary

Xinghua Zhu

Role: primary

Zhibo Liao

Role: primary

Muqun Shen

Role: primary

Zhiqiang Xue

Role: primary

Youhe Li

Role: primary

Huaiyuan Mao

Role: primary

Yanqiang Peng

Role: primary

Yubin Xia

Role: primary

Jinxiong Xu

Role: primary

Hongbo Ye

Role: primary

Yaoli Huang

Role: primary

Bin Zhou

Role: primary

Bing Zhou

Role: primary

Min He

Role: primary

Zhihua Zheng

Role: primary

Zibo Xiong

Role: primary

Jihong Chen

Role: primary

Lifen Wang

Role: primary

Mingliang Hu

Role: primary

Tiecheng Yang

Role: primary

Mou Liang

Role: primary

Xianrui Dou

Role: primary

Lingjun Zeng

Role: primary

Yang Chen

Role: primary

Yingchao Zhong

Role: primary

Yong Su

Role: primary

Chifeng Wang

Role: primary

Xinyuan Liao

Role: primary

Huafeng Liu

Role: primary

Lei Zeng

Role: primary

Hua Tang

Role: primary

Jinquan Wu

Role: primary

Qing Ye

Role: primary

Xianggeng Chi

Role: primary

Juan Pang

Role: primary

Cheng Wang

Role: primary

Rui Zhang

Role: primary

Liaohua Qu

Role: primary

Xucheng Li

Role: backup

Jie Wang

Role: primary

Zhenhua Yang

Role: primary

Li Zhao

Role: primary

Yansong Xu

Role: primary

Xianfeng Cheng

Role: primary

Yongjun Zhu

Role: primary

Jiali Wei

Role: primary

Bo Zhang

Role: primary

Jian Chen

Role: primary

Yuan Tian

Role: primary

Xiaotie Tang

Role: primary

Caixia Song

Role: primary

Wenli Chen

Role: primary

Chun Zhang

Role: primary

Gang Xu

Role: primary

Yanmin Zhang

Role: primary

Hai Yuan

Role: primary

Yumei Liang

Role: primary

Hao Zhang

Role: primary

Xiangcheng Xiao

Role: primary

Weidong Yuan

Role: primary

Xinglei Zhou

Role: primary

Guangyu Bi

Role: primary

Zhuo Li

Role: primary

Hongxia Peng

Role: primary

Xiaoran Feng

Role: primary

Aimin Zhong

Role: primary

Qinkai Chen

Role: primary

Menghua Chen

Role: primary

Rongguo Fu

Role: primary

Li Wang

Role: primary

Minfeng Liang

Role: primary

Yuxia Zhong

Role: primary

Shanshan Zhou

Role: primary

Jie Guo

Role: primary

Xiaoping Yang

Role: primary

Jinfeng Guo

Role: primary

Jianghua Chen

Role: primary

Lie Jin

Role: primary

Other Identifiers

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GDPH-CH-2774

Identifier Type: -

Identifier Source: org_study_id

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