Reviewer ’s report  
 
Title: Novel 1L polyethylene glycol -based bowel preparation (NER1006): proof of concept 
assessment versus standard 2L polyethylene glycol with ascorbate - a randomized parallel group 
Phase 2 colonoscopist -blinded trial  
 
Version: 0 Date: 09 Nov 2018  
 
Reviewer: Fabrizio Parente  
 
Reviewer's report:  
 
From the gastroenterologist's perspective the concept of optimal bowel cleansing prior to 
colonoscopy is for a preparation to be well tolerated, s afe and effective, allowing a complete 
visualization of the bowel mucosa in order to detect all possible mucosal lesions. In this regard, 
patient adherence to the bowel cleansing regimen is vital. From the patient's perspective, bowel 
preparation needs abo ve all to be well tolerated to be an effective product. Indeed, poor tolerance 
of the bowel cleansing regimen can negatively impact adherence, leading to a reduction in 
efficacy.  
The rate of poor colonoscopy preparation in most prospective studies is usual ly reported between 
15 and 30% among patients using the PEG -based solution. Prior studies have demonstrated that 
2 litres PEG split -based bowel preparations are as effective as 4 litres split -based bowel 
preparation but much better tolerated expecially by elderly people who have already problems 
with fluid intake. In this connection, the development of new effective bowel preparation at 
lower liquid volume may further increase patients' compliance to colonoscopy.  
 Aim of the present study was twofold: first , an initial study in order to explore, among four new 
test formulations based on  PEG + Asc., the two products most suitable for further clinical 
investigation; second, to evaluate, in an endoscopist -blinded trial, the efficacy of the two selected 
variant  preparations, compared to the control 2L PEG + Asc. regimen, in patients undergoing 
screening colonoscopy, by evaluating the mean 24 -hour stool weight and the bowel cleansing 
success (Harefield Cleansing Scale).  
The article is interesting and well writte n, since describes the modalities of development of the 
new 1L PEG+Asc acid compound, recently launched on the pharmaceutical market by Norgine 
Ltd;  however, I think it is most suitable to a pharmacological rather than a gastroenterological 
journal.  
  
Minor comments:  
The manuscript contains too much Tables and Figures, which can be easily condensed into 3 -4 
pages at most.  
Are the methods appropriate 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 s hown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional statistical review?  
If an additional statistical review is recommended, please specify what aspec ts require further  
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
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, fees, funding, or salary from an  
organisation that may in any way gain or lose financially from the publication of this  
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that 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 received reimbursements, fees, funding, or salary from an organization that 
holds  or has applied fo r 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 h ave no competing interests' 
below.  If your reply is yes to any, please give details below.  
 
I declare that I have no competing interests  
 
I agree to the open peer review policy of the journal. I understand that my name will be included  
on my report to the au thors and, if the manuscript is accepted for 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 confidential comments  
to the editors, which will not be published.  
 
I agree to the open peer review policy of the journal  
Reviewer ’s report  
 
Title: Novel 1L polyethylene glycol -based bowel preparation (NER1006): proof of concept 
assessment versus standard 2L polyethylene glycol with ascorbate - a randomized parallel group 
Phase 2 colonoscopist -blinded trial  
 
Version: 0 Date: 09 Nov 2018  
 
Reviewer: Fabrizio Parente  
 
Reviewer's report:  
 
From the gastroenterologist's perspective the concept of optimal bowel cleansing prior to 
colonoscopy is for a preparation to be well tolerated, s afe and effective, allowing a complete 
visualization of the bowel mucosa in order to detect all possible mucosal lesions. In this regard, 
patient adherence to the bowel cleansing regimen is vital. From the patient's perspective, bowel 
preparation needs abo ve all to be well tolerated to be an effective product. Indeed, poor tolerance 
of the bowel cleansing regimen can negatively impact adherence, leading to a reduction in 
efficacy.  
The rate of poor colonoscopy preparation in most prospective studies is usual ly reported between 
15 and 30% among patients using the PEG -based solution. Prior studies have demonstrated that 
2 litres PEG split -based bowel preparations are as effective as 4 litres split -based bowel 
preparation but much better tolerated expecially by elderly people who have already problems 
with fluid intake. In this connection, the development of new effective bowel preparation at 
lower liquid volume may further increase patients' compliance to colonoscopy.  
 Aim of the present study was twofold: first , an initial study in order to explore, among four new 
test formulations based on  PEG + Asc., the two products most suitable for further clinical 
investigation; second, to evaluate, in an endoscopist -blinded trial, the efficacy of the two selected 
variant  preparations, compared to the control 2L PEG + Asc. regimen, in patients undergoing 
screening colonoscopy, by evaluating the mean 24 -hour stool weight and the bowel cleansing 
success (Harefield Cleansing Scale).  
The article is interesting and well writte n, since describes the modalities of development of the 
new 1L PEG+Asc acid compound, recently launched on the pharmaceutical market by Norgine 
Ltd;  however, I think it is most suitable to a pharmacological rather than a gastroenterological 
journal.  
  
Minor comments:  
The manuscript contains too much Tables and Figures, which can be easily condensed into 3 -4 
pages at most.  
Are the methods appropriate 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 s hown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional statistical review?  
If an additional statistical review is recommended, please specify what aspec ts require further  
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
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, fees, funding, or salary from an  
organisation that may in any way gain or lose financially from the publication of this  
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that 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 received reimbursements, fees, funding, or salary from an organization that 
holds  or has applied fo r 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 h ave no competing interests' 
below.  If your reply is yes to any, please give details below.  
 
I declare that I have no competing interests  
 
I agree to the open peer review policy of the journal. I understand that my name will be included  
on my report to the au thors and, if the manuscript is accepted for 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 confidential 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: Novel 1L polyethylene glycol -based bowel preparation (NER1006): proof of concept 
assessment versus standard 2L polyethylene glycol with ascorbate - a randomized parallel group 
Phase 2 colonoscopist -blinded trial  
 
Version: 0 Date: 09 Nov 2018  
 
Reviewer: Fabrizio Parente  
 
Reviewer's report:  
 
From the gastroenterologist's perspective the concept of optimal bowel cleansing prior to 
colonoscopy is for a preparation to be well tolerated, s afe and effective, allowing a complete 
visualization of the bowel mucosa in order to detect all possible mucosal lesions. In this regard, 
patient adherence to the bowel cleansing regimen is vital. From the patient's perspective, bowel 
preparation needs abo ve all to be well tolerated to be an effective product. Indeed, poor tolerance 
of the bowel cleansing regimen can negatively impact adherence, leading to a reduction in 
efficacy.  
The rate of poor colonoscopy preparation in most prospective studies is usual ly reported between 
15 and 30% among patients using the PEG -based solution. Prior studies have demonstrated that 
2 litres PEG split -based bowel preparations are as effective as 4 litres split -based bowel 
preparation but much better tolerated expecially by elderly people who have already problems 
with fluid intake. In this connection, the development of new effective bowel preparation at 
lower liquid volume may further increase patients' compliance to colonoscopy.  
 Aim of the present study was twofold: first , an initial study in order to explore, among four new 
test formulations based on  PEG + Asc., the two products most suitable for further clinical 
investigation; second, to evaluate, in an endoscopist -blinded trial, the efficacy of the two selected 
variant  preparations, compared to the control 2L PEG + Asc. regimen, in patients undergoing 
screening colonoscopy, by evaluating the mean 24 -hour stool weight and the bowel cleansing 
success (Harefield Cleansing Scale).  
The article is interesting and well writte n, since describes the modalities of development of the 
new 1L PEG+Asc acid compound, recently launched on the pharmaceutical market by Norgine 
Ltd;  however, I think it is most suitable to a pharmacological rather than a gastroenterological 
journal.  
  
Minor comments:  
The manuscript contains too much Tables and Figures, which can be easily condensed into 3 -4 
pages at most.  
Are the methods appropriate 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 s hown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional statistical review?  
If an additional statistical review is recommended, please specify what aspec ts require further  
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
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, fees, funding, or salary from an  
organisation that may in any way gain or lose financially from the publication of this  
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that 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 received reimbursements, fees, funding, or salary from an organization that 
holds  or has applied fo r 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 h ave no competing interests' 
below.  If your reply is yes to any, please give details below.  
 
I declare that I have no competing interests  
 
I agree to the open peer review policy of the journal. I understand that my name will be included  
on my report to the au thors and, if the manuscript is accepted for 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 confidential comments  
to the editors, which will not be published.  
 
I agree to the open peer review policy of the journal  
assistant