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MM1: Describing Study Design and Subjects

MM1-Step1: Describing study design

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	ex.
	ex.
	ex. study was conducted according to
	ex.
	ex.
	ex.
	ex.
	ex.
	ex. methods have been described previously
	ex. have been described in detail elswhere
	ex. The protocol and statistical analysis plan have been published previously.

MM1-Step2: Describing selection of participants

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	ex.
	ex.
	ex. Patients were eligible to participate in the study if
	ex.
	ex.
	ex.
	ex.
	ex.
	ex.
	ex.
	ex.
	ex.
	ex.
		ex.
	ex.
	ex.
	exclusion creteria are listed in
		ex. Detailed inclusion and exclusion creteria are provided in Table.1
	ex.
	ex.

 

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		ex.
		ex. patients were randomly assigned to receive
		ex.
		ex.
	ex.
	ex.
	ex.
	ex.
	ex.

MM1-Step3: Describing ethics

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		ex.
		ex.
	ex.
	ex.
	ex.
	ex. an independent data and safty monitoring committee reviewed safty data

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	ex. study was conducted according to the principles of the Declaration of Helsinki
	ex.

MM1-Step3c��Informed consent��

		ex. all patients provided written informed consent before enrollment

MM1-Step4: Describing role and responsibility

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made the decision to submit	ex. All of the authors made the decision to submit the manuscript for publication.
authors vouch for the accuracy	ex. All the authors vouch for the accuracy and completeness of the data.
for the fidelity of	ex. All of the authors vouch for the fidelity of the study to the protocol.
	ex. the sponsor was responsible for

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draft of the manuscript was written by	ex. The first draft of the manuscript was written by the first author
	ex. The trial was desined by the sponsor
	ex. The study was designed by the first author
	ex. protocol was developed by the sponsor
	ex. data were collected by the investigators
	ex. All the authors had full access to the data

MM2: Describing Research Methodology

MM2-Step1: Describing procedure

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	ex.

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were given	ex.
	ex.
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	ex. done at the descretion of

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MM2-Step2: Describing evaluation

MM2-Step2a��End point��

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	ex.
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	ex.

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		ex.
		ex.
	ex.
	ex.
	ex.
	ex. we assessed the methodological quality of
	ex. we assessed symptoms
	ex.
	ex.
	ex.
	ex.
	ex.
	ex.
	ex.

MM2-Step2d��Adverse events��

		ex.
	ex.

MM3: Describing Statistical Analysis

MM3-Step1: Restating subjects

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	ex.
	ex.
	ex.
	ex.
	ex. study is registered with ClinicalTrials.gov, number
	ex. trial is registered with ClinicalTrials.gov, number
	ex.
	ex.
	ex. we calcuated that a sample of * patients would

MM3-Step2: Describing statistical procedures

MM3-Step2a��Statistical analysis: was/were pp��

			ex. All analyses were performed with the use of SAS software
			ex. All analyses were conducted using SAS
			ex. analyses were done with SAS
			ex.
	ex. were analysed with the use of Fisher's extract test
	ex. were estimated with the use of the Kaplan-Meier method
	ex. were  compared with the use of the long-rank test
		ex. were compared between groups with Fisher's extract test
		ex.
		ex. were calculated with the use of a Cox proportional-hazards model
		ex. Fisher's exact test was used to compare
		ex. Cox proportional-hazards model was used to estimate
		ex.
	ex.
	ex. the proportional hazards assumption was tested

MM3-Step2b��Statistical analysis: we��

	we used SAS	ex. We used Cox proportional hazards models
	we used Stata	ex.
		ex. We used the chi-square test to compare
	ex. We performed all statistical analyses using
	ex. we carried out sensitivity analyses
	ex.
	ex.
	We analysed data using SAS

MM3-Step2c��Statistical analysis condition��

		ex.
	ex.	ex.
	ex. analyzed in the intention-to-treat population
	ex.
	ex.
	ex. we calculated that we would need to enroll * patients
	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
	ex. the study would have 80% power to detect
	ex. a sample of * patients would provide 90% power to detect
	ex. * participants per group would provide 80% power to detect
provide the study with *% power to detect
	ex. would provide a power of 90% to detect
	ex.
	ex.
	ex. Assuming a *% rate of loss to follow-up, we

MM3-Step3: Describing the purpose of analysis

MM3-Step3a��Purpose of analysis��

	ex.
	ex.
	ex.
	ex.
	ex.
	ex.
	ex. to assess the robustness of our findings
	ex.
	ex.
	ex.
	ex.
	ex.
	ex.

MM3-Step4: Describing criteria for statistical significance or data expression

MM3-Step4a��P value��

a P value of less than
considered to indicate statistical significance	ex. A P value less than 0.005 was considered to indicate statistical significance
considered statistically significant	ex. A P value less than 0.05 was considered statistically significant
to be significant	ex. We considered P values less than 0.05 to be significant
a significance level of	ex. using a two-sided log-rank test with a significance level of 0.05
a two-sided significance level of	ex. using a two-sided significance level of 0.05
at a two-sided alpha level of	ex. test was conducted at a two-sided alpha level of 0.01
at a one-sided alpha level of
P values are two-sided	ex. All reported P values are two-sided
tests were two-sided	ex. All statistical tests were two-sided

 

MM3-Step4b��Data expression��

	ex. are reported as means and standard deviations
	ex. All data are presented as means ��SD
	ex. Continuous variables were expressed means ��SD

MM4: Describing Role of Funding Source

MM4-Step1: Describing role of funders

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		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	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
	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

MM4-Step2: Describing authors�� responsibility

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The corresponding author had full access to all the data	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
All authors had access to
The corresponding author had final responsibility for the decision	ex. The corresponding author had final responsibility for the decision to submit for publication.