Reviewer ’s report  
 
Title: NON -INFERIORITY COMPARATIVE CLINICAL TRIAL BETWEEN EARLY ORAL  
REFEEDING AND USUAL ORAL REFEEDING IN PREDICTED MILD ACUTE BILIARY  
PANCREATITIS  
 
Version: 2 Date: 17 Feb 2020  
 
Reviewer's report:  
 
Thank you very much for giving me the opportunity to review this manuscript. This study was 
interesting to show the early oral refeeding is safe in mild acute pancreatitis patients, without 
adverse gastrointestinal events, and reduce the hospital s tay and cost compared with usual oral 
refeeding. The purpose of this study is very important. Now, there are a few questions, and the 
following comments should be addressed.  
 
The sump size calculation does not seem reasonable. Usually non -inferiority trial s require a large 
sample size. It seems that the tolerance range for non -inferiority was incorrect.  
 
Discussion session is slightly poor. The RCT of early feeding for mild acute pancreatitis has 
been reported recently 
(https://www.sciencedirect.com/science /article/pii/S0899900720300071?via%3Dihub). Please 
discuss using this manuscript.  
 
Are the methods appropr iate and well described?  
If not, please specify what is required in your comments to the authors.  
 
Yes 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manus cript or would you recommend an 
additional statistical review?  
If an additional statist ical review is recommended, please speci fy what aspects require further 
assessment in your comments to the editors.  
 
I recommend additional statistical review  
 
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, f ees, funding, or salary from an 
organisation that may in any way gain or lose financial ly from the publication of this 
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares  in an organisation t hat may in any way gain or lose 
financially from the publication of this manuscript, either now or in the future?  
 
3. Do you hold or are you currently applying for any patents  relating to the content of the 
manuscript?  
 
4. Have you recei ved reimbursements, fees, funding, or salary from an organization that 
holds or has applied for patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
If you can answer no to all of the above, write 'I declare that I have  no competing interests' 
below. If your reply is yes to any, please give details below.  
 
None 
 
I agree to the open peer review policy  of the journal. I understan d that my name will be included 
on my report to the authors and, if the manuscript is accepted f or publication, my named  report 
including any attachments I upload will be posted on the website along with the authors' 
responses. I agree for my report to be made available under an Open Access Creative Commons 
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments 
which I do not wish to be included in my named report can be included as confidenti al comments 
to the editors, which will not be published.  
 
I agree to the open peer review policy of the journal  
Reviewer ’s report  
 
Title: NON -INFERIORITY COMPARATIVE CLINICAL TRIAL BETWEEN EARLY ORAL  
REFEEDING AND USUAL ORAL REFEEDING IN PREDICTED MILD ACUTE BILIARY  
PANCREATITIS  
 
Version: 2 Date: 17 Feb 2020  
 
Reviewer's report:  
 
Thank you very much for giving me the opportunity to review this manuscript. This study was 
interesting to show the early oral refeeding is safe in mild acute pancreatitis patients, without 
adverse gastrointestinal events, and reduce the hospital s tay and cost compared with usual oral 
refeeding. The purpose of this study is very important. Now, there are a few questions, and the 
following comments should be addressed.  
 
The sump size calculation does not seem reasonable. Usually non -inferiority trial s require a large 
sample size. It seems that the tolerance range for non -inferiority was incorrect.  
 
Discussion session is slightly poor. The RCT of early feeding for mild acute pancreatitis has 
been reported recently 
(https://www.sciencedirect.com/science /article/pii/S0899900720300071?via%3Dihub). Please 
discuss using this manuscript.  
 
Are the methods appropr iate and well described?  
If not, please specify what is required in your comments to the authors.  
 
Yes 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manus cript or would you recommend an 
additional statistical review?  
If an additional statist ical review is recommended, please speci fy what aspects require further 
assessment in your comments to the editors.  
 
I recommend additional statistical review  
 
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, f ees, funding, or salary from an 
organisation that may in any way gain or lose financial ly from the publication of this 
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares  in an organisation t hat may in any way gain or lose 
financially from the publication of this manuscript, either now or in the future?  
 
3. Do you hold or are you currently applying for any patents  relating to the content of the 
manuscript?  
 
4. Have you recei ved reimbursements, fees, funding, or salary from an organization that 
holds or has applied for patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
If you can answer no to all of the above, write 'I declare that I have  no competing interests' 
below. If your reply is yes to any, please give details below.  
 
None 
 
I agree to the open peer review policy  of the journal. I understan d that my name will be included 
on my report to the authors and, if the manuscript is accepted f or publication, my named  report 
including any attachments I upload will be posted on the website along with the authors' 
responses. I agree for my report to be made available under an Open Access Creative Commons 
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments 
which I do not wish to be included in my named report can be included as confidenti al comments 
to the editors, which will not be published.  
 
I agree to the open peer review policy of the journal  
Please review this paper.
user
Reviewer ’s report  
 
Title: NON -INFERIORITY COMPARATIVE CLINICAL TRIAL BETWEEN EARLY ORAL  
REFEEDING AND USUAL ORAL REFEEDING IN PREDICTED MILD ACUTE BILIARY  
PANCREATITIS  
 
Version: 2 Date: 17 Feb 2020  
 
Reviewer's report:  
 
Thank you very much for giving me the opportunity to review this manuscript. This study was 
interesting to show the early oral refeeding is safe in mild acute pancreatitis patients, without 
adverse gastrointestinal events, and reduce the hospital s tay and cost compared with usual oral 
refeeding. The purpose of this study is very important. Now, there are a few questions, and the 
following comments should be addressed.  
 
The sump size calculation does not seem reasonable. Usually non -inferiority trial s require a large 
sample size. It seems that the tolerance range for non -inferiority was incorrect.  
 
Discussion session is slightly poor. The RCT of early feeding for mild acute pancreatitis has 
been reported recently 
(https://www.sciencedirect.com/science /article/pii/S0899900720300071?via%3Dihub). Please 
discuss using this manuscript.  
 
Are the methods appropr iate and well described?  
If not, please specify what is required in your comments to the authors.  
 
Yes 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manus cript or would you recommend an 
additional statistical review?  
If an additional statist ical review is recommended, please speci fy what aspects require further 
assessment in your comments to the editors.  
 
I recommend additional statistical review  
 
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, f ees, funding, or salary from an 
organisation that may in any way gain or lose financial ly from the publication of this 
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares  in an organisation t hat may in any way gain or lose 
financially from the publication of this manuscript, either now or in the future?  
 
3. Do you hold or are you currently applying for any patents  relating to the content of the 
manuscript?  
 
4. Have you recei ved reimbursements, fees, funding, or salary from an organization that 
holds or has applied for patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
If you can answer no to all of the above, write 'I declare that I have  no competing interests' 
below. If your reply is yes to any, please give details below.  
 
None 
 
I agree to the open peer review policy  of the journal. I understan d that my name will be included 
on my report to the authors and, if the manuscript is accepted f or publication, my named  report 
including any attachments I upload will be posted on the website along with the authors' 
responses. I agree for my report to be made available under an Open Access Creative Commons 
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments 
which I do not wish to be included in my named report can be included as confidenti al comments 
to the editors, which will not be published.  
 
I agree to the open peer review policy of the journal  
assistant