气滞证及其亚型证量表信度校度与诊断效能评价研究

注册号:

Registration number:

ITMCTR2100005248

最近更新日期:

Date of Last Refreshed on:

2021-08-28

注册时间:

Date of Registration:

2021-08-28

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

气滞证及其亚型证量表信度校度与诊断效能评价研究

Public title:

Research on reliability and validity and diagnostic efficacy evaluation of Qi Stagnation Syndrome and Its Subtype Syndrome Scale

注册题目简写:

English Acronym:

研究课题的正式科学名称:

气滞证及其亚型证量表信度校度与诊断效能评价研究

Scientific title:

Research on reliability and validity and diagnostic efficacy evaluation of Qi Stagnation Syndrome and Its Subtype Syndrome Scale

研究课题的正式科学名称简写:

Scientific title acronym:

研究课题代号(代码):

Study subject ID:

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

ChiCTR2100050545 ; ChiMCTR2100005248

申请注册联系人:

方格

研究负责人:

胡志希

Applicant:

Fang Ge

Study leader:

Hu Zhi-xi

申请注册联系人电话:

Applicant telephone:

18719139564

研究负责人电话:

Study leader's telephone:

13574812411

申请注册联系人传真 :

Applicant Fax:

研究负责人传真:

Study leader's fax:

申请注册联系人电子邮件:

Applicant E-mail:

20202063@stu.hnucm.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

003405@hnucm.edu.cn

申请单位网址(自愿提供):

Study leader's website(voluntary supply):

研究负责人网址(自愿提供):

Study leader's website
(voluntary supply):

申请注册联系人通讯地址:

湖南省长沙市岳麓区学士街道学士路300号湖南中医药大学

研究负责人通讯地址:

湖南省长沙市岳麓区学士街道学士路300号湖南中医药大学

Applicant address:

Hunan University of Chinese Medicine, No.300, Xueshi Road, Science and education Park, Yuelu District, Changsha City, Hunan Province, 410208, P.R China

Study leader's address:

Hunan University of Chinese Medicine, No.300, Xueshi Road, Science and education Park, Yuelu District, Changsha City, Hunan Province, 410208, P.R China

申请注册联系人邮政编码:

Applicant postcode:

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

湖南中医药大学中医学院

Applicant's institution:

College of Traditional Chinese Medicine of Hunan University of Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

HN-LL-KY-2021-021-01

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

湖南中医药大学第一附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Hunan University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2021/7/10 0:00:00

伦理委员会联系人:

雍苏南、喻珮

Contact Name of the ethic committee:

Yong Su-nan, Yu Pei

伦理委员会联系地址:

湖南省长沙市雨花区韶山中路95号杏源大酒店10楼会议室

Contact Address of the ethic committee:

Conference Room, 10th Floor, Xingyuan Hotel, 95 Shaoshan Middle Road, Yuhua District, Changsha City, Hunan Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

伦理委员会联系人邮箱:

Contact email of the ethic committee:

研究实施负责(组长)单位:

湖南中医药大学

Primary sponsor:

Hunan University of Chinese Medicine

研究实施负责(组长)单位地址:

湖南省长沙市岳麓区学士街道学士路300号湖南中医药大学

Primary sponsor's address:

Hunan University of Chinese Medicine, No.300, Xueshi Road, Science and education Park, Yuelu District, Changsha City, Hunan Province, 410208, P.R China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖南省

市(区县):

Country:

China

Province:

Hunan

City:

单位(医院):

湖南中医药大学

具体地址:

长沙市岳麓区学士街道学士路300号湖南中医药大学

Institution
hospital:

Hunan University of Chinese Medicine

Address:

Hunan University of Chinese Medicine, No.300, Xueshi Road, Science and education Park, Yuelu District, Changsha City, China

经费或物资来源:

广东省政府基金

Source(s) of funding:

Guangdong Provincial Government Fund

研究疾病:

抑郁症、慢性非萎缩性胃炎、围绝经期综合征、乳腺癌、冠心病、慢性阻塞性肺疾病

研究疾病代码:

Target disease:

Depression, chronic non-atrophic gastritis, perimenopausal syndrome, breast cancer, coronary heart disease, chronic obstructive pulmonary disease

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

横断面

Cross-sectional

研究所处阶段:

Study phase:

其它

Others

研究目的:

对《气滞证及其亚型证量表》信度效度及诊断效能评价,为气滞证临床量化诊断提供依据。

Objectives of Study:

Evaluation of the reliability, validity and diagnostic efficacy of the Scale of Qi Stagnation Syndrome and its Subtype Syndrome provides a basis for the clinical quantitative diagnosis of Qi stagnation syndrome.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)抑郁症 1) 符合上述西医疾病诊断标准(轻、中度抑郁症)及中医证候诊断标准; 2) 20 分≤汉密尔顿抑郁量表(HAMD-24)总分<35 分; 3) 符合抑郁症首次发作患者; 4) 符合抑郁症原发性的患者; 5) 生命体征平稳,神志清楚,具有一定表达; 6) 2 周内未服用抗抑郁中、西药物者; 7) 年龄 18~65 岁(包含 18 及 65 岁),性别不限; 同时符合上述七项者,方可入选。 (2)慢性非萎缩性胃炎 1)西医标准:符合慢性非萎缩性胃炎的疾病诊断标准:内镜下可见黏膜红斑,黏膜出血点或斑块,伴或不伴水肿,及充血渗出等基本表现;病理诊断:Hp 感染等。 2)中医胃肠气滞证诊断:窜满闷痛,遇情志不遂易诱发或加重、情志抑郁或急躁易怒、肠鸣、矢气、嗳气、呃逆、太息、纳呆、嗳腐吞酸、呕吐、腹泻、口苦、腹部时聚包块、舌质淡红、舌质暗、苔薄白、苔薄黄、苔腻、苔白、脉弦、脉沉、脉滑,将采用量表进行辨证诊断。 3)虚实转化其它证候,参照慢性非萎缩性胃炎中西医结合诊疗共识意见(2017年)和慢性胃炎中医诊疗专家共识意见(2017年)。 (3)围绝经期综合征 1)西医标准:参考世界中医药学会联合会及中华中医药学会公布的《国际中医临床实践指南 更年期综合征(2020-10-11)》的诊断标准:由于卵巢功能衰退引起的一系列以自主神经系统功能紊乱为主,伴有神经心理症状的一组症候群。卵巢功能评价等实验室检查有助于诊断。 2)中医肝郁气滞证诊断:胸胁脘腹胀窜满闷痛、情志抑郁或急躁易怒、太息、咽喉异物感、痛经、月经不调、失眠、矢气、大便秘结、纳呆、舌质淡红、舌质暗、苔薄白、苔薄黄、脉弦,将采用量表进行辨证诊断。 3)虚实转化其它证候,参照《国际中医临床实践指南》(2020-10-11)。 (4)乳腺癌 1)西医标准:参照《中国抗癌协会乳腺癌诊治指南与规范 (2019年版)》,最终由病理诊断确认。 2)中医肝郁气滞证诊断:胸胁脘腹胀窜满闷痛、情志抑郁或急躁易怒、太息、咽喉异物感、痛经、月经不调、失眠、矢气、大便秘结、纳呆、舌质淡红、舌质暗、苔薄白、苔薄黄、脉弦,将采用量表进行辨证诊断。 3)虚实转化其它证候,参照第十版教材陈红风主编的《中医外科学》。 (5)冠心病 1)西医标准:参照中华医学会心血管病学分会介入心脏病学组2018年公布《稳定性冠心病诊断与治疗指南》及国家卫生计生委合理用药专家委员会2018年公布的《冠心病合理用药指南(第2版)》的稳定性冠心病诊断标准:(1)胸部不适,通常位于胸骨体之后,可波及心前区,有手掌大小范围,甚至横贯前胸,界限不很清楚。常放射至左肩、左臂内侧达无名指和小指,或至颈、咽或下颌部。(2)胸痛常为压迫、发闷、紧缩或胸口沉重感,有时被描述为颈部扼制或胸骨后烧灼感,但不像针刺或刀扎样锐性痛。可伴有呼吸困难,也可伴有非特异性症状如乏力或虚弱感、头晕、恶心、坐立不安或濒死感。胸痛发作时,患者往往被迫停止正在进行的活动, 直至症状缓解。(3)通常持续数分钟至10余分钟 ,大多数情况下3~5 min,很少超过30min。(4)与劳累或情绪激动相关。(5)负荷心电图:负荷运动过程中心电图2个以上导联J点后0.06~0.08 s的 ST 段出现水平或下斜性下移≥0.1 mV。但约15% 的SCAD患者,具有诊断意义的ST段变化发生在负荷试验恢复期。(6)负荷超声心动图:以室壁增厚异常作为缺血的标志。(7)左心室功能有明显减退者。(8)使用正电子发射断层扫描进行心肌灌注显像发现缺血范围>1%。(9)冠状动脉CT血管造影发现有明显狭窄者(10)冠状动脉造影有明显狭窄者 2)中医心脉气滞证诊断:窜满闷痛遇情志不遂时易诱发或加重、气短、心悸、情志抑郁或急躁易怒、太息、失眠、少痰、舌质淡红、舌质暗、苔薄白、苔薄腻、脉弦、脉沉弦,将采用量表进行辨证诊断。 3)虚实转化其它证候,参照2020年中华中医药学会心血管病分会发布的《冠心病稳定型心绞痛中医诊疗指南》。 (6)慢性阻塞性肺疾病 1)西医标准:参照中华医学会呼吸病学分会慢性阻塞性肺疾病学组2021年公布《慢性阻塞性肺疾病诊治指南》及中华医学会2018年公布的《慢性阻塞性肺疾病基层诊疗指南(2018年)》的慢性阻塞性肺疾病诊断标准:1.年龄≥40岁和(或)有危险因素暴露史,有慢性咳嗽、咳痰、呼吸困难等症状。2.肺功能检查表现为持续气流受限,吸入支气管舒张剂后FEV1/FVC<70% 即明确存在持续的气流受限。3.符合慢性阻塞性肺疾病诊断,存在口唇、甲床发绀、颈静脉怒张、桶状胸、呼吸次数、呼吸音、啰音、心率、心律、双下肢浮肿、杵状指(趾)。 2)中医肺气郁闭证诊断:窜满闷痛遇情志不遂时易诱发或加重、气喘、咳嗽、气短、情志抑郁或急躁易怒、太息、咯痰、少痰、舌质淡红、舌质暗、苔薄白、苔薄腻、脉弦、脉沉弦,将采用量表进行辨证诊断。 3)虚实转化其它证候,参照世界中医药学会联合会发布的的《国际中医临床实践指南:慢性阻塞性肺疾病》。

Inclusion criteria

(1) Depression 1) Comply with the above-mentioned Western medical disease diagnostic criteria (mild and moderate depression) and TCM syndrome diagnostic criteria; 2) 20 points ≤ Hamilton Depression Rating Scale (HAMD-24) total score <35 points; 3) In line with the first episode of depression; 4) Patients with primary depression; 5) The vital signs are stable, conscientious, and expressive; 6) Those who have not taken Chinese or Western antidepressant drugs within 2 weeks; 7) 18 to 65 years old (including 18 and 65 years old), regardless of gender; Only those who meet the above seven items at the same time can be selected. (2) Chronic non-atrophic gastritis 1) Western medical standards: in line with the diagnostic criteria of chronic non-atrophic gastritis: mucosal erythema, mucosal bleeding points or plaques, with or without edema, and congestion and exudation can be seen under endoscopy; pathological diagnosis: Hp infection, etc. . 2) Diagnosis of gastrointestinal qi stagnation syndrome in traditional Chinese medicine: full of suffocation and pain, easily induced or aggravated by emotional insufficiency, emotional depression or irritability, bowel, qi, belching, hiccups, too much breath, appetite, belching Acid, vomiting, diarrhea, bitter mouth, lump in the abdomen, pale red tongue, dark tongue, thin white coating, thin yellow coating, greasy coating, white coating, stringy pulse, heavy pulse, slippery pulse. Table for dialectical diagnosis. 3) Deficiency and actual transformation of other syndromes, refer to the consensus opinion on the diagnosis and treatment of chronic non-atrophic gastritis with integrated traditional Chinese and western medicine (2017) and the consensus opinion on the diagnosis and treatment of chronic gastritis with traditional Chinese medicine (2017). (3) Perimenopausal syndrome 1) Western medical standards: refer to the diagnostic criteria of "International Clinical Practice Guidelines for Menopausal Syndrome (2020-10-11)" published by the World Federation of Chinese Medicine Societies and the Chinese Society of Chinese Medicine A group of syndromes with mainly nervous system dysfunction, accompanied by neuropsychological symptoms. Laboratory tests such as ovarian function evaluation are helpful for diagnosis. 2) Diagnosis of the syndrome of stagnation of liver and qi in traditional Chinese medicine: chest and hypogastric abdominal distension, fullness and pain, emotional depression or irritability, too much rest, foreign body sensation in the throat, dysmenorrhea, irregular menstruation, insomnia, qi, constipation, anorexia , Red tongue, dark tongue, thin white coating, thin yellow coating, stringy pulse, the scale will be used for dialectical diagnosis. 3) For the transformation of other syndromes from deficiency to reality, refer to "International Clinical Practice Guidelines of Traditional Chinese Medicine" (2020-10-11). (4) Breast cancer 1) Western medical standards: refer to the "Guidelines and Norms for the Diagnosis and Treatment of Breast Cancer of the Chinese Anti-Cancer Association (2019 Edition)", and finally confirmed by pathological diagnosis. 2) Diagnosis of the syndrome of stagnation of liver and qi in traditional Chinese medicine: chest and hypogastric abdominal distension, fullness and pain, emotional depression or irritability, too much rest, foreign body sensation in the throat, dysmenorrhea, irregular menstruation, insomnia, qi, constipation, anorexia , Red tongue, dark tongue, thin white coating, thin yellow coating, stringy pulse, the scale will be used for dialectical diagnosis. 3) To transform other syndromes from false to actual, refer to "Traditional Chinese Medicine Surgery" edited by Chen Hongfeng, the tenth edition of the textbook. (5) Coronary heart disease 1) Western medical standards: refer to the "Guidelines for the Diagnosis and Treatment of Stable Coronary Heart Disease" published by the Interventional Cardiology Group of the Cardiovascular Branch of the Chinese Medical Association in 2018 and the "Rational Use of Coronary Heart Disease Drugs" published by the National Health and Family Planning Commission Expert Committee on Rational Use in 2018 Guidelines (Second Edition)" Stable Coronary Heart Disease Diagnostic Criteria: (1) Chest discomfort, usually located behind the body of the sternum, can spread to the precordial area, with the palm size range, even across the front chest, the boundary is not very clear. It often radiates to the left shoulder, inner left arm, to the ring finger and little finger, or to the neck, pharynx, or jaw. (2) Chest pain is often compression, tightness, tightness, or a feeling of heaviness in the chest. It is sometimes described as a suffocation of the neck or a burning sensation behind the breastbone, but it is not as sharp as acupuncture or knife sticking. It can be accompanied by dyspnea or non-specific symptoms such as fatigue or weakness, dizziness, nausea, restlessness, or a sense of dying. When chest pain occurs, patients are often forced to stop their ongoing activities until the symptoms are relieved. (3) It usually lasts from a few minutes to more than 10 minutes, in most cases 3~5 minutes, rarely more than 30 minutes. (4) It is related to fatigue or emotional agitation. (5) Stress ECG: The ST segment of 0.06~0.08 s after the J point of more than 2 leads of the ECG during the stress exercise shows a horizontal or downward shift of ≥0.1 mV. However, in about 15% of SCAD patients, the ST-segment changes with diagnostic significance occur during the recovery period of the stress test. (6) Stress echocardiography: abnormal ventricular wall thickening is used as a sign of ischemia. (7) Patients with significant reduction in left ventricular function. (8) Myocardial perfusion imaging using positron emission tomography revealed that the ischemia range was >1%. (9) Patients with obvious stenosis found on coronary CT angiography (10) Patients with obvious stenosis on coronary angiography 2) Diagnosis of the syndrome of qi stagnation in the heart and pulse of traditional Chinese medicine: it is easy to induce or aggravate when suffering from emotional discomfort, shortness of breath, palpitations, emotional depression or irritability, too much rest, insomnia, little phlegm, pale red tongue, tongue texture For dark, thin and white fur, thin and greasy fur, stringy pulse, and heavy pulse, the scale will be used for diagnosis. 3) Deficiency and actual transformation of other syndromes, refer to the "Guidelines for the Diagnosis and Treatment of Stable Angina Pectoris of Coronary Heart Disease" issued by the Cardiovascular Branch of the Chinese Society of Chinese Medicine in 2020. (6) Chronic obstructive pulmonary disease 1) Western medical standards: refer to the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease" published by the Chronic Obstructive Pulmonary Disease Group of the Respiratory Medicine Branch of the Chinese Medical Association in 2021 and the "Guidelines for the Primary Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease" published by the Chinese Medical Association in 2018 ( 2018)" Diagnosis criteria for chronic obstructive pulmonary disease: 1. Age ≥40 years old and/or history of exposure to risk factors, chronic cough, sputum expectoration, dyspnea and other symptoms. 2. Pulmonary function examination showed continuous airflow limitation, FEV1/FVC<70% after inhalation of bronchodilator, it is clear that there is continuous airflow limitation. 3. Comply with the diagnosis of chronic obstructive pulmonary disease, with cyanosis of the lips, nail bed, distended jugular vein, barrel chest, breathing frequency, breath sounds, rales, heart rate, heart rhythm, edema of both lower limbs, clubbing (toe). 2) TCM diagnosis of lung-qi stagnation closed syndrome: when suffering from emotional discomfort, it is easily induced or aggravated, wheezing, coughing, shortness of breath, emotional depression or irritability, too much breath, expectoration, little sputum, pale red tongue , Dark tongue, thin and white fur, thin and greasy fur, pulse string, pulse string, the scale will be used for dialectical diagnosis. 3) Deficiency and actual transformation of other syndromes, refer to the "International Clinical Practice Guidelines of Traditional Chinese Medicine: Chronic Obstructive Pulmonary Disease" issued by the World Federation of Chinese Medicine Societies.

排除标准:

(1)抑郁症 1) 存在分裂性症状或精神分裂症后出现的抑郁; 2) 有证据表明抑郁发作与躯体疾病有病因关系; 3) 属于抑郁症复发的患者妊娠或哺乳期妇女; 4) 不符合纳入标准, 或资料不全等影响观察者; 符合上述其中一项者, 即予排除。 (2)慢性非萎缩性胃炎 排除萎缩性胃炎和排除特殊类型胃炎。 (3)围绝经期综合征 1)合并严重肝肾等脏器功能严重失调或肿瘤者; 2)妊娠或哺乳期妇女; 3)研究者认为存在不适合参加本研究的其他情况。 (4)乳腺癌 排除非乳腺癌疾病,肝肾功能不全、高泌乳症、全身感染性疾病、内分泌异常患者。 (5)冠心病 1)合并严重肝肾等脏器功能严重失调或肿瘤者; 2)妊娠或哺乳期妇女; 3)研究者认为存在不适合参加本研究的其他情况。 (6)慢性阻塞性肺疾病 排除其他心、肺疾患(如肺结核、肺尘埃沉着病、慢性阻塞性肺疾病、支气管扩张、肺癌、心脏病、心功能不全、慢性鼻炎等)引起的咳嗽、咳痰或伴有喘息等。

Exclusion criteria:

(1) Depression 1) Existence of schizophrenia or depression after schizophrenia; 2) There is evidence that there is a etiological relationship between depressive episodes and physical diseases; 3) Pregnant or breastfeeding women who belong to patients who have relapsed depression; 4) Non-compliance with the inclusion criteria, or incomplete information affects the observer; Those that meet one of the above will be excluded. (2) Chronic non-atrophic gastritis Exclude atrophic gastritis and special types of gastritis. (3) Perimenopausal syndrome 1) Patients with severe liver and kidney dysfunction or tumors; 2) Pregnant or lactating women; 3) The researcher believes that there are other situations that are not suitable for participating in this research. (4) Breast cancer Exclude patients with non-breast cancer diseases, liver and kidney dysfunction, high lactation, systemic infectious diseases, and endocrine abnormalities. (5) Coronary heart disease 1) Patients with severe liver and kidney dysfunction or tumors; 2) Pregnant or lactating women; 3) The researcher believes that there are other situations that are not suitable for participating in this research. (6) Chronic obstructive pulmonary disease Exclude other heart and lung diseases (such as tuberculosis, pneumoconiosis, chronic obstructive pulmonary disease, bronchiectasis, lung cancer, heart disease, heart failure, chronic rhinitis, etc.) caused by cough, sputum or wheezing.

研究实施时间:

Study execute time:

From 2021-09-15

To      2023-12-31

征募观察对象时间:

Recruiting time:

From 2021-09-15

To      2023-12-31

干预措施:

Interventions:

组别:

Case series

样本量:

600

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

样本总量 Total sample size : 600

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

长沙市

市(区县):

Country:

China

Province:

Changsha City

City:

单位(医院):

湖南中医药大学第一附属医院

单位级别:

三级甲等

Institution/hospital:

The First Affiliated Hospital of Hunan University of Chinese Medicine

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

长沙市

市(区县):

Country:

China

Province:

Changsha City

City:

单位(医院):

湖南中医药研究院附属医院

单位级别:

三级甲等

Institution/hospital:

Affiliated Hospital of Hunan Academy of Chinese Medicine

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

长沙市

市(区县):

Country:

China

Province:

Changsha City

City:

单位(医院):

湖南省脑科医院

单位级别:

三级甲等

Institution/hospital:

Hunan Provincial Brain Hospital

Level of the institution:

Tertiary A hospital

测量指标:

Outcomes:

指标中文名:

量表

指标类型:

主要指标

Outcome:

Scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后保存

说明

Fate of sample 

Preservation after use

Note:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 85
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

Randomization Procedure (please state who generates the random number sequence and by what method):

None

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

Yes

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

原始数据可根据合理要求从研究负责人处获得

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The original data can be obtained from the research leader on reasonable request

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case Record Form

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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