|
隐蔽分组方法和过程：
|
采用两级盲法设计，第一级为各病例号所对应的组别（如A组或B组），第二级为各组所对应的处理（试验组或对照组）。随机编码表由第三方人员建立，两级盲底分别单独密封，各一式二份，分别存放于研究人员及第三方人员处。每一编码的试验用药均有对应的应急信件，应急信件内装有该编码药物属何种类的纸条，以便发生紧急情况下破盲用。应急信件由研究人员保存，非必要时不得拆阅。在发生紧急情况（如严重不良事件），或受试者需要抢救必须知道该受试者接受的是何种处理时，由研究人员拆阅。一旦被拆阅，该编号受试者将退出试验，按脱落病例处理，研究者应将退出原因记录在病例报告表中。所有应急信件在试验结束后随病例报告表一起收回，以便试验结束后盲态审核。当病例报告表全部录入后，数据被锁定后进行第一次揭盲（即明确A组、B组），之后交由统计学专业人员统计分析。当统计分析结束后进行第二次揭盲，明确试验组和对照组。
|
|
Process of allocation
concealment：
|
Using a two-stage blind design, the first level is the corresponding group of each case number (e. g., Group A or Group B), and the second level is the treatment corresponding to each group (test group or control group). The random code table is established by a third party, and the two-level blind bases are sealed separately in duplicate with the researcher and the third party respectively. Each coded test drug has a corresponding emergency letter, which contains a note of what kind of the coded drug is, in order to break the blinding use in an emergency. Emergency letters should be kept by researchers and should not be read unless necessary. In an emergency (e. g. serious adverse event), or when the subject needs rescue and must know what the subject is doing. Once reviewed, the numbered subject will withdraw from the trial, treated as a shedding case, and the investigator shall record the reason for withdrawal, in the case report form. All emergency letters were withdrawn with the case report form after the trial for blinded review after the trial. When all the case report forms are entered, the data are locked for the first unblinding (i. e., clear A group, B group), and then submitted to statistical professionals for statistical analysis. When the statistical analysis was completed, the test group and the control group were identified.
|
|
盲法：
|
采用两级盲法设计，第一级为各病例号所对应的组别（如A组或B组），第二级为各组所对应的处理（试验组或对照组）。随机编码表由第三方人员建立，两级盲底分别单独密封，各一式二份，分别存放于研究人员及第三方人员处。当病例报告表全部录入后，数据被锁定后进行第一次揭盲（即明确A组、B组），之后交由统计学专业人员统计分析。当统计分析结束后进行第二次揭盲，明确试验组和对照组。
|
|
Blinding：
|
Using a two-stage blind design, the first level is the corresponding group of each case number (e. g., Group A or Group B), and the second level is the treatment corresponding to each group (test group or control group). The random code table is established by a third party, and the two-level blind bases are sealed separately in duplicate with the researcher and the third party respectively.When all the case report forms are entered, the data are locked for the first unblinding (i. e., clear A group, B group), and then submitted to statistical professionals for statistical analysis. When the statistical analysis was completed, the test group and the control group were identified.
|
|
揭盲或破盲原则和方法：
|
每一编码的试验用药均有对应的应急信件，应急信件内装有该编码药物属何种类的纸条，以便发生紧急情况下破盲用。应急信件由研究人员保存，非必要时不得拆阅。在发生紧急情况（如严重不良事件），或受试者需要抢救必须知道该受试者接受的是何种处理时，由研究人员拆阅。一旦被拆阅，该编号受试者将退出试验，按脱落病例处理，研究者应将退出原因记录在病例报告表中。所有应急信件在试验结束后随病例报告表一起收回，以便试验结束后盲态审核。
|
|
Rules of uncover or
ceasing blinding：
|
Each coded test drug has a corresponding emergency letter, which contains a note of what kind of the coded drug is, in order to break the blinding use in an emergency. Emergency letters should be kept by researchers and should not be read unless necessary. In an emergency (e. g. serious adverse event), or when the subject needs rescue and must know what the subject is doing. Once reviewed, the numbered subject will withdraw from the trial, treated as a shedding case, and the investigator shall record the reason for withdrawal, in the case report form. All emergency letters were withdrawn with the case report form after the trial for blinded review after the trial.
|
|
统计方法名称：
|
采用SPSS 25.0统计软件分析。计量资料以±s表示，如符合正态分布和方差齐性要求，比较组内差异采用配对样本t检验，比较组间差异采用独立样本t检验；若数据不符合正态分布，则采用非参数检验。非等级计数资料采用卡方检验，等级计数资料采用秩和检验。P<0.05表示差异有统计学意义。
|
|
Statistical method：
|
Analysis was performed using the SPSS 25.0 statistical software. The measurement data are expressed as ± s. If the requirements meet the normal distribution and homogeneity of variance, paired-sample t-test and independent sample t-test are used for the comparison of differences between groups; if the data do not meet the normal distribution, non-parametric test is used. Non-rank count data were tested by chi-square test and rank-sum test for rank count data. P <0.05 indicates a statistical significance.
|
|
试验完成后的统计结果（上传文件）：
|
|
|
Calculated Results ater
the Study Completed：
|
|
|
上传试验完成后的统计结果：
Statistical results after completion of the test file upload
|
|
|
是否公开试验完成后的统计结果：
Calculated Results after
the Study Completed(upload file)：
|
公开
Public
|
|
全球唯一识别码：
UTN
|
|
