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隐蔽分组方法和过程：
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采用信封法进行随机分组，在密闭不透光信封内装有 A 或 B 两个字母，共72 封（编号 1-72），规定字母 A 数试验组，B 为对照组，受试者随机抽取一封，由第三方人员（机构）保留分组结果，记录后将信封再次密封
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Process of allocation
concealment：
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The envelope method was used for random grouping. Two letters A or B were placed in the sealed light-proof envelope, with A total of 72 letters (no. 1-72). According to the letter A number test group, B was the control group
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盲法：
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指定一个研究者负责只对受试者进行纳入、出组、不良事件监察等，指定另一个研究者对受试者进行访视及病例报告表记录，指定一名药品管理员只对试验组受试者进行发药及药品回收，并且保留由第三方人员（机构）所提供的分组结果，便于记录药物使用情况。规定指定人员各自与受试者单独联系，指定人员之间相互不能联系。如果某受试者发生严重不良事件经研究者评估符合紧急揭盲条件，研究者联系第三方人员（机构）获取受试者编号后，打开信封，获取该受试者的用药具体信息。
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Blinding：
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Specify a researcher is responsible for only the subjects into and out of the group, adverse event monitoring, etc., specify another researchers for the subjects to conduct supervision and case report form records, specify a drug administrator only the experimental group subjects in medicine and drugs, and retain staff by third parties (institutions) provided by the group as a result, easy to record drug usage.It is stipulated that the designated person shall contact with the subject separately, and the designated person shall not contact with each other.If a subject has a serious adverse event and is evaluated by the investigator as meeting the criteria for emergency unblinding, the investigator contacts a third party (institution) to obtain the subject number, then opens the envelope to obtain the specific medication information of the subject.
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揭盲或破盲原则和方法：
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当病例报告表数据录入数据库并核对无误后，由数据管理员写出数据库核查报告。在盲态审核会议上，由主要研究者、申办者、监查员、数据管理员和生物统计专业人员对试验过程盲态保持情况和试验过程中的紧急揭盲情况等做出审核，并对数据库检查报告中提出的问题做出决议，并写出盲态审核报告。数据库同时被锁定。 数据锁定后由保存盲底的人员进行揭盲，交由生物统计学专业人员输入计算机，与数据文件进行联接后，进行统计分析。
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Rules of uncover or
ceasing blinding：
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When the case report form data is entered into the database and checked, the data manager writes the database check report.In the blind state audit meeting, the main researcher, sponsor, supervisor, data manager and biometric professional staff shall audit the blind state maintenance in the test process and the emergency unblinding in the test process, and make resolutions on the problems raised in the database inspection report, and write the blind state audit report.The database is locked at the same time.After the data is locked, the blind is unblinded by the person who keeps the blind bottom, and the blind is input into the computer by the professional biostatistician. After the data is connected with the data file, statistical analysis is carried out.
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统计方法名称：
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与筛选期基线值进行比较，采用配 t 检验比较组内前后差异（或秩和检验），多次测量 的数据采用方差分析（ANOVA），两两比较采用SNK。组间治疗前后的变化采用方差分析进行比较。对于数据不符合上述统计分析条件者（如非正态），将采用非参数检验，等级资料作 Ridit 检验。相关性分析采用 Logistic 回归分析，计量资料将采用均数±标准差进行统计 描述。对于连续的数值变量，使用 Shapiro-Wilk 检验其正态性，使用 Mann-WhitneyU 检验 进行组间比较。无序的分类变量则以频数（百分比）表示，使用 Fisher 精确检验进行组间比较。使用 Spearman 相关分析评估同一基因不同 CpG 位点的甲基化水平各位点间的两两相关性。
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Statistical method：
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Comparisons were made with the baseline values during the screening period, and intra-group differences (or rank-sum test) were compared using the paired t-test, ANOVA was used for multiple measurements, and SNK was used for pairwise comparisons.The changes before and after treatment were compared by anova.If the data does not meet the requirements of the above statistical analysis (such as non-normal), a non-parametric test will be used, and the grade data will be tested by Ridit.Logistic regression analysis was used for correlation analysis, and mean ± standard deviation was used for statistical description of measurement data.For continuous numerical variables, shapiro-wilk was used to test their normality, and mann-whitneyu test was used for inter-group comparison.The unordered categorical variables were expressed as frequency (percentage), and the Fisher's exact test was used for inter-group comparisons.Spearman correlation analysis was used to evaluate the pair-to-pair correlation of methylation levels at different CpG sites in the same gene.
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试验完成后的统计结果（上传文件）：
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Calculated Results ater
the Study Completed：
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上传试验完成后的统计结果：
Statistical results after completion of the test file upload
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是否公开试验完成后的统计结果：
Calculated Results after
the Study Completed(upload file)：
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公开
Public
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全球唯一识别码：
UTN
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