【Key phrases for MM1, MM2, MM3, and MM4】
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＜MM1: Describing Study Design and Subjects＞
＜MM1-Step1: Describing study design＞
MM1-Step1a（Procedure）
ex. study was conducted at * sites EtoJ
ex. study was conducted from * to
ex. study was conducted according to EtoJ
ex. we conducted a retrospective cohort study EtoJ
randomized, double-blind, placebo-controlled EtoJ
ex. randomized, double-blind, placebo-controlled trial EtoJ
ex. we developed a * model EtoJ
ex. was administered orally at a dose of EtoJ
have been described previously EtoJ
ex. methods have been described previously EtoJ
have been reported previously EtoJ
been published previously EtoJ
ex. have been described in detail elsewhere EtoJ
statistical analysis plan EtoJ
ex. The protocol and statistical analysis plan have been published previously.
＜MM1-Step2: Describing selection of participants＞
MM1-Step2a（Eligibility）
ex. Patients were eligible if they were aged 18 years or older EtoJ
were eligible for inclusion if they EtoJ
ex. Patients were eligible for inclusion if they EtoJ
were eligible to participate EtoJ
ex. Patients were eligible to participate in the study if
were * years of age or older EtoJ
ex. Eligible patients were 18 years of age or older
ex. To be eligible for inclusion EtoJ
ex. patients were enrolled at * sites EtoJ
ex. patients were included if they EtoJ
ex. patients were included in EtoJ
ex. participants were recruited from EtoJ
ex. were invited to participate EtoJ
ex. we selected * patients EtoJ
eligibility criteria included EtoJ
ex. eligibility criteria included an age of EtoJ
were excluded if they had EtoJ
ex. Patients were excluded if they had EtoJ
exclusion criteria included EtoJ
exclusion criteria are listed in EtoJ
inclusion and exclusion criteria EtoJ
ex. Detailed inclusion and exclusion criteria are provided in Table 1.
patients were required to have EtoJ
ex. disease was defined as EtoJ
MM1-Step2b（Grouping）
were randomly assigned in a EtoJ
ex. were randomly assigned in a 1:1 ratio to EtoJ
were randomly assigned to EtoJ
ex. patients were randomly assigned to receive EtoJ
ex. patients were randomly assigned to one of
patients were randomly assigned EtoJ
ex. Eligible patients were randomly assigned EtoJ
participants were randomly assigned EtoJ
randomization was performed EtoJ
ex. randomization was performed with the use of EtoJ
randomization was stratified according to EtoJ
ex. Randomization was stratified according to the presence or absence of
ex. randomisation was computer-generated EtoJ
ex. were masked to treatment assignment EtoJ
ex. assessors were masked to group allocation EtoJ
＜MM1-Step3: Describing ethics＞
MM1-Step3a（Approval）
was approved by the institutional review board EtoJ
ex. the protocol was approved by the institutional review board EtoJ
was approved by the ethics committee EtoJ
ex. study was approved by the ethics committee
ex. institutional review board approved the protocol EtoJ
ex. ethics committee approved the study EtoJ
approval was obtained from EtoJ
ex. Ethics approval was obtained from EtoJ
independent data and safety monitoring EtoJ
ex. an independent data and safety monitoring committee reviewed safety data EtoJ
MM1-Step3b（Declaration）
principles of the Declaration of Helsinki EtoJ
ex. study was conducted according to the principles of the Declaration of Helsinki EtoJ
conducted in accordance with EtoJ
ex. study was conducted in accordance with the Declaration of Helsinki EtoJ
MM1-Step3c（Informed consent）
provided written informed consent EtoJ
all patients provided written informed consent EtoJ
ex. all patients provided written informed consent before enrollment
all participants provided written informed consent EtoJ
gave written informed consent EtoJ
written informed consent was obtained from EtoJ
ex. written informed consent was obtained from all participants
＜MM1-Step4: Describing role and responsibility＞
MM1-Step4a（Responsibility）
made the decision to submit EtoJ
ex. All of the authors made the decision to submit the manuscript for publication. EtoJ
authors vouch for the accuracy EtoJ
ex. All the authors vouch for the accuracy and completeness of the data
for the fidelity of EtoJ
ex. All of the authors vouch for the fidelity of the study to the protocol.
ex. the sponsor was responsible for EtoJ
MM1-Step4b（Role）
draft of the manuscript was written by EtoJ
ex. The first draft of the manuscript was written by the first author
ex. The trial was designed by the sponsor EtoJ
ex. The study was designed by the first author EtoJ
ex. protocol was developed by the sponsor EtoJ
ex. data were collected by the investigators EtoJ
ex. All the authors had full access to the data EtoJ
＜MM2: Describing Research Methodology＞
＜MM2-Step1: Describing procedure＞
MM2-Step1a（Source）
ex. data were obtained from EtoJ
ex. samples were collected in EtoJ
ex. samples were obtained at baseline and at EtoJ
ex. information was obtained EtoJ
ex. we collected information on EtoJ
ex. DNA was extracted from EtoJ
ex. two reviewers independently extracted data EtoJ
MM2-Step1b（Procedure）
ex. administered if the patient EtoJ
ex. receive * at a dose of * mg EtoJ
ex. concentrations were determined by EtoJ
ex. a lower limit of quantification of EtoJ
and every * weeks thereafter EtoJ
ex. at baseline and every * weeks thereafter EtoJ
ex. weeks after the end of treatment EtoJ
ex. done at the discretion of
MM2-Step1c（Instruction）
ex. participants were asked to complete EtoJ
ex. patients were instructed to EtoJ
＜MM2-Step2: Describing evaluation＞
MM2-Step2a（End point）
the primary end point was EtoJ
ex. the primary end point was a composite of EtoJ
ex. the primary end point was progression-free survival EtoJ
the primary efficacy end point was EtoJ
ex. the primary efficacy end point was the proportion of EtoJ
ex. The primary outcome was all-cause mortality EtoJ
secondary end points were EtoJ
ex. secondary end points were the time to EtoJ
ex. secondary end points included the rate of EtoJ
ex. primary end point was a composite of death EtoJ
ex. primary outcome was the proportion of patients with EtoJ
ex. primary end point was the rate of death from any cause EtoJ
MM2-Step2b（Criteria）
ex. disease was defined as EtoJ
ex. patients were classified as EtoJ
ex. we classified participants as EtoJ
MM2-Step2c（Evaluation）
ex. was assessed with the use of EtoJ
ex. were assessed at baseline EtoJ
ex. was assessed on the basis of
ex. quality of life was assessed EtoJ
ex. we assessed the methodological quality of EtoJ
ex. we assessed symptoms EtoJ
ex. assessments were performed EtoJ
ex. questionnaire was used to assess EtoJ
ex. responses were confirmed EtoJ
ex. disagreements were resolved by consensus EtoJ
ex. participants were considered to EtoJ
ex. were blinded to treatment assignment EtoJ
MM2-Step2d（Adverse events）
adverse events were graded EtoJ
ex. adverse events were graded according to the Common Terminology Criteria for Adverse Events
ex. events were adjudicated by * committee EtoJ
＜MM3: Describing Statistical Analysis＞
＜MM3-Step1: Restating subjects＞
MM3-Step1a（Subjects）
ex. patients who received at least one dose of EtoJ
ex. patients who underwent randomization EtoJ
included all patients who EtoJ
ex. safety analyses included all patients who received at least one dose of study drug
all randomly assigned patients EtoJ
ex. included all randomly assigned patients who received EtoJ
study is registered with ClinicalTrials.gov, number EtoJ
trial is registered with ClinicalTrials.gov, number EtoJ
ex. data were censored at the time of EtoJ
ex. the sample size was calculated EtoJ
ex. we calculated that a sample size of * patients would EtoJ
＜MM3-Step2: Describing statistical procedures＞
MM3-Step2a（Statistical analysis: was/were pp）
statistical analyses were EtoJ
analyses were performed with the use of EtoJ
ex. All analyses were performed with the use of SAS software
analyses were performed using EtoJ
analyses were conducted using EtoJ
ex. All analyses were conducted using SAS
analyses were conducted with the use of EtoJ
ex. All analyses were done with SAS
ex. analyses were done by EtoJ
ex. were analyzed with the use of Fisher's exact test EtoJ
estimated with the use of EtoJ
ex. were estimated with the use of the Kaplan-Meier method EtoJ
ex. were compared with the use of the log-rank test EtoJ
ex. were compared between groups with EtoJ
ex. were compared between groups with Fisher's exact test EtoJ
ex. rates were calculated for each EtoJ
calculated with the use of EtoJ
ex. were calculated with the use of a Cox proportional-hazards model EtoJ
95% confidence intervals were calculated EtoJ
ex. Fisher's exact test was used to compare EtoJ
ex. Cox proportional-hazards model was used to estimate EtoJ
ex. Logistic regression was used to estimate EtoJ
ex. chi-square test was used for EtoJ
the proportional hazards assumption was EtoJ
ex. the proportional hazards assumption was tested EtoJ
MM3-Step2b（Statistical analysis: we）
we used SAS EtoJ
we used Stata
we used logistic regression to EtoJ
ex. We used Cox proportional hazards models EtoJ
ex. We used the Kaplan-Meier method to estimate EtoJ
ex. We used the chi-square test to compare EtoJ
ex. We performed all statistical analyses using EtoJ
we conducted sensitivity analyses EtoJ
ex. we carried out sensitivity analyses EtoJ
ex. we calculated hazard ratios EtoJ
ex. we estimated odds ratios EtoJ
We analysed data using SAS EtoJ
MM3-Step2c（Statistical analysis condition）
the intention-to-treat principle EtoJ
according to the intention-to-treat principle EtoJ
ex. analyses were performed according to the intention-to-treat principle
ex. based on the intention-to-treat principle
ex. analyses were based on the intention-to-treat principle
in the intention-to-treat population EtoJ
ex. analyzed in the intention-to-treat population
ex. analysed in intention-to-treat population EtoJ
on an intention-to-treat basis EtoJ
ex. analyses were performed on an intention-to-treat basis EtoJ
ex. we calculated that we would need to enroll * patients EtoJ
ex. we calculated that a sample of * patients would provide
ex. we estimated that a sample of * patients would be needed
ex. for the study to have 90% power EtoJ
ex. the study would have 80% power to detect EtoJ
provide *% power to detect EtoJ
ex. a sample of * patients would provide 90% power to detect EtoJ
ex. * participants per group would provide 80% power to detect EtoJ
provide the study with *% power to detect
ex. would provide a power of 90% to detect EtoJ
regression models with adjustment for EtoJ
ex. to test the null hypothesis EtoJ
ex. the assumption of proportional hazards EtoJ
ex. Assuming a *% rate of loss to follow-up, we EtoJ
for the primary end point EtoJ
ex. Hazard ratios for the primary end point EtoJ
＜MM3-Step3: Describing the purpose of analysis＞
MM3-Step3a（Purpose of analysis）
ex. to assess the effect of EtoJ
ex. to examine the effect of EtoJ
ex. to evaluate the effect of EtoJ
to * the association between EtoJ
ex. to assess the association between EtoJ
ex. to estimate the association between EtoJ
ex. to test the robustness of EtoJ
ex. to assess the robustness of our findings EtoJ
ex. we compared the number of EtoJ
ex. we estimated the effect of EtoJ
ex. we assessed the effect of EtoJ
＜MM3-Step4: Describing criteria for statistical significance or data expression＞
MM3-Step4a（P value）
considered to indicate statistical significance EtoJ
ex. A P value of less than 0.05 was considered to indicate statistical significance. EtoJ
considered statistically significant EtoJ
ex. A P value less than 0.05 was considered statistically significant. EtoJ
ex. We considered P values less than 0.05 to be significant. EtoJ
ex. using a two-sided log-rank test with a significance level of 0.05
a two-sided significance level of EtoJ
ex. was used at a two-sided significance level of 0.05
at a two-sided alpha level of EtoJ
ex. test was conducted at a two-sided alpha level of 0.01
at a one-sided alpha level of
ex. All reported P values are two-sided EtoJ
ex. All statistical tests were two-sided EtoJ
MM3-Step4b（Data expression）
as means and standard deviations EtoJ
ex. are reported as means and standard deviations EtoJ
ex. All data are presented as means ±SD EtoJ
ex. Continuous variables were expressed means ±SD EtoJ
＜MM4: Describing Role of Funding Source＞
＜MM4-Step1: Describing role of funders＞
MM4-Step1a（Role）
The funding source had no role in EtoJ
ex. The funding source had no role in the design, conduct, or analysis of the study or the decision to submit the manuscript for publication.
The sponsor of the study had no role in EtoJ
ex. The sponsor of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.
The sponsors of the study had no role in EtoJ
The funders had no role in
The funder of the study had no role in
The funders of the study had no role in
The funding source played no role in EtoJ
＜MM4-Step2: Describing authors’ responsibility＞
MM4-Step2a（Responsibility）
The corresponding author had full access to all the data EtoJ
ex. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
All authors had full access to all the data EtoJ
All authors had access to EtoJ
The corresponding author had final responsibility for the decision EtoJ
ex. The corresponding author had final responsibility for the decision to submit for publication.