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. 2023 May 9;15:1153973. doi: 10.3389/fnagi.2023.1153973

Table 1.

Institutions involved in the study.

Institution City Role and activity Work package
Peking University Third Hospital Beijing Coordinating center Convene expert committee, formulate the protocol and create the case report form (CRF) with statistics unit.
Submit application to ethical committees.
Train the protocol and outcomes measure.
Present and disseminate the results with the permission of the sponsor.
Enroll and follow-up the subjects.
The Second Hospital of Hebei Medical University Shijiazhuang Enrolling center Participate in the seminar on protocol formulation and provide suggestions.
Henan Provinclal People’s Hosipital Zhengzhou Complete the training of the protocol and outcomes measure.
The First Affiliated Hosipital, Sun Yat-Sen University Guangzhou
Enroll and follow-up at least four subjects.
Guangdong Province Traditional Chinese Medical Hospital Guangzhou
The Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou
West China Hospital of Sichuan University Chengdu
The First Affiliated Hospital of Xi’an Jiaotong University Xi’an
Fujian Medical University Union Hospital Fuzhou
The First Affiliated Hospital of Harbin Medical University Harbin
Renmin Hospital of Wuhan University Wuhan
/ / Independent Data Monitoring Committee Safety monitoring, efficacy monitoring, operational quality control, and suggestions for adjustment of trial design.
Conduct an interim analysis and assess the risks and benefits for the subjects.
Make a key recommendation whether the trial continues.
Wuhan Zhizhi Medical and Pharmaceutical Technology Co., Ltd. Wuhan Statistics unit Participate in the design of the protocol and statistical plans.
Establishment and management of Electronic Data Capture System and central randomization system.
Blind codes.
Statistical analysis.
Beijing Qi-Huang Technology Co., Ltd. Beijing Contract Research Organization Monitor the trial.
Foshan Kaichuan Pharma Co., Ltd., Shanghai Pharma Rare Disease Medicine Co., Ltd Foshan Shanghai sponsor and funders Provide funding.
Provide HLSJ, riluzole tablets and simulants.
Present and disseminate the results.
Medkey Med-Tech Development Co., Ltd. Shanghai Site Management Organization Assist investigators in completing the screening, enrolling, and follow-up of the subjects.