PONE-D-21-08484

Goal Management Training and Psychoeducation for Treatment of Executive Dysfunction in Parkinson’s disease: A Feasibility Pilot Trial.

PLOS ONE

Dear Dr. Giguère-Rancourt,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by Jun 19 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

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If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

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We look forward to receiving your revised manuscript.

Kind regards,

Walid Kamal Abdelbasset, Ph.D.

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Partly

Reviewer #3: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Thank you for giving me the opportunity to review this article.

Abstract:

1. Mention the acronym of abbreviations when it is used for first time. (GMT, PDQ, DEX, ZMT etc..)

2. Include the study design, randomization and allocation procedure.

3. Mention the treatment for the both groups.

4. Results part should be more informative including CI 95% with p scores.

5. Make the conclusion more precise and avoid abbreviations.

Introduction

6. Please change the reference pattern as per author guidelines.

7. Please avoid subtitles.

8. How come this pilot study is differing from (McLean et al., 2017 and Stamenova & Levine, 2019 studies?

9. The introduction part fails to show the research gap and prove the novelty with recent references.

10. Add the clinical significance of this article over the participants and researchers.

Methods

11. Include the clinical trial registration number.

12. Include the study design, randomization and allocation procedure in detail.

13. Mention the selection criteria in detail (exclusion).

14. Include the intervention procedures in detail for study repetition.

15. Whether the interventions are performed at clinic? If performed at clinic means, how they are monitored?

16. Include the reliability and validity of outcome measures with references.

17. What is the need of doing sample size calculation as it is a feasibility pilot trial.

18. Mention about the blinding procedure.

Results

19. Include the information about the test used for analyzing homogeneity and its interpretation.

20. Include the reports with CI 95% with p scores.

21. Mention the effect size of primary and secondary variables and its MCID scores.

Discussion

22. Summarize the discussion part.

23. The discussion part should discuss the relation between the outcome variables and PD patients with latest references.

24. Make the conclusion more precise and avoid abbreviations.

25. Future recommendations and clinical significance of the study is missing.

Reviewer #2: In this study, the authors examined feasibility and preliminary efficacy of two home-based cognitive interventions in patients with Parkinson’s disease and mild cognitive impairment. Six patients experiencing executive dysfunction were randomized to each intervention, which consisted of weekly 60-90 minute sessions for five weeks. Measures were collected at baseline, mid-point, one-week, four week and 12-week follow-ups. Executive functions were assessed by the DEX questionnaire and Zoo Map Test. Secondary outcomes were quality of life and presence of psychiatric symptoms.

On the Consort checklist, the authors have entered that information on the registration of the trial, and the availability of the trial protocol, are “N/A.” This information (as follows) is provided in a letter to the editor, but should also be included in the manuscript:

“In the compressed file uploaded, you will find the originial protocol that was accepted by the Ethical Committee of CHU de Québec - Université Laval, as well as the last confirmation letter sent by the ethical committee. As you will see, the original documents are in French. In order to provide an english translation, we attached the Clinicaltrial.gov registration that explains the ethically approved protocol in English. The clinicaltrial.gov number of the trial is: NCT04636541.”

The study has a number of strengths. The authors have done an excellent job of justifying and describing the tests used in the study, and of explaining the test modifications and reasons for these in the cohort. Obtaining neuropsychological measurements at baseline is also a strength of the study. The analyses are clearly described and the paper has been nicely and clearly written. I do have some comments and questions, however.

Methods

• Were the same mindfulness exercises used for both groups?

• Did authors adjust for time spent doing mindfulness exercises between sessions in the GMT group?

• In the psychoeducation group? Did these differ between the two groups?

• Are there different versions of the ZMT or are patients repeating the same test/questions each time they are evaluated?

• Power analysis: What “effect size” in the study did the authors base the power calculation on? Change in DEX scores? Change in ZMT? Feasibility (if so, please define how this was measured in terms of sample size calculation)? Was the study powered for feasibility or efficacy? The authors should clarify. Also, please explain what a “medium” effect size means in terms of the quantitative measurement scores/changes (or whatever the primary measure was on which the power was calculated).

Results

• The authors should not assume that the two groups are comparable at baseline. In terms of LED and some of the Screening Neuropsychological Evaluation tests (Lexical fluency, NAB, e.g.), results appear quite different, and the non-significant p-values are likely due to a lack of power to detect differences (given the very small sample size). This should be acknowledged in the results in addition to being discussed as a limitation.

• The authors state in the Methods that non-parametric tests were used to compare groups. Data in Table 1 should therefore be summarized with non-parametric measures (median, IQR). If variables are actually normally distributed, they should be summarized with means and standard deviations and compared using parametric tests, which are more powerful when data are normally distributed.

Results

• In presenting the results, are the authors equating safety with feasibility? Given that “the aim of this pilot study was to test ease of implementation, differential safety and preliminary efficacy,” a section that addresses feasibility should be presented in the results section, probably prior to the sections on efficacy (for which the study was not really powered, I don’t think?).

• Results for DEX (self-report) are given “regardless of group.” Do the authors mean that all twelve patients were analyzed together? This should be more clearly stated, and analyses over the entire group should be distinguished from analyses between groups throughout the Results section.

• Post-hoc analyses should not be done if the omnibus test is not significant. I think it is fine for the authors to give these data descriptively, without p-values attached/interpreted.

• Again, given the very small sample size, an absence of difference between groups has not been shown, as this could be a power issue. The study has not been powered to detect interactions, which would be difficult to see with such a small sample size. Adjusting for covariates also has little chance of resulting in significance. The authors would do well to be more descriptive in presenting results. Although I appreciate the fact that the authors have used repeated measures analyses, they should acknowledge that given the small sample size, these would be unlikely to have significant results. Conclusions should not be based on not finding significant differences between groups.

• DEX-C: post-hoc analyses are not really appropriate here and should be excluded.

Discussion

• Discussion of feasibility results should be given precedence over “preliminary efficacy” in the discussion section. The authors, in discussing feasibility, should address the obvious fact that while at-home, highly individualized programs are more likely to be successful than not, they are also expensive and difficult to implement on a large scale. They are expensive in terms of the time of those administering the tests/services and conducting these in the home also requires scheduling effort and additional traveling time. This seems like the biggest drawback to this type of intervention and should definitely be discussed. Would insurance pay for this type of intervention? Because of the progressive nature of PD, it would have to be ongoing, and not a one-time intervention, which is also a concern in terms of cost.

• “Patients with longer disease duration registered improvement while their DRS-II scores were inferior to those with shorter disease duration, suggesting they benefited from interventions despite a more global cognitive impairment.” This is very likely due to regression to the mean.

• The assumption that patients if the psychoeducation/mindfulness group were motivated by their intervention to practice mindfulness between sessions is just an assumption. Involvement in a trial is also well-known to influence the behavior of the “control” group to adopt “intervention” practices.

• “…this sample size is typical for this kind of phase 1 study in the field of cognitive intervention.” Please omit this statement. I do not feel that doing something because “everyone else does it” is a valid justification. The reasons the authors have given sufficiently address this point.

• Again, the labor-intensive/expensive nature of the intervention should be addressed as a limitation.

Overall, this study has been nicely done and was a pleasure to review. I do feel that the authors should be more conservative in their conclusions, however, since the study was not powered for anything other than preliminary efficacy. It nonetheless offers important information on an intervention that has promise and in an area where it is widely needed. But more emphasis needs to be placed on feasibility of implementation than on efficacy, since the study is clearly underpowered to detect differences between the two groups, and a finding of “no difference” doesn’t mean there is no difference.

Reviewer #3: thanks alot for effort in this paper

i have minor issues want to be clear

Introduction

need editing and rewrite

Abstract:

Methods section is poorly framed. It has to be re-written.

Demographic profile of patients is not mentioned clear

Discussion:

needs to be as per well defined objectives

Describe sources of potential bias and imprecision

It has to be framed in such a way that readers are able to have good understanding of the current evidences and rationale of the paper

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6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: Gopal Nambi

Reviewer #2: No

Reviewer #3: No

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

PONE-D-21-08484R1Goal Management Training and Psychoeducation / Mindfulness for Treatment of Executive Dysfunction in Parkinson’s disease: A Feasibility Pilot Trial.PLOS ONE

Dear Dr. Giguère-Rancourt,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

==============================

Please submit your revised manuscript by Jan 13 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Walid Kamal Abdelbasset, Ph.D.

Academic Editor

PLOS ONE

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #3: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #3: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #3: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #3: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #3: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Reviewer comments

Thank you for giving me this opportunity to review this article.

Abstract:

1. Summarize the abstract (follow the abstract guidelines).

2. Include the study duration and eligibility criteria of study participants.

3. Mention the reports with 95%CI (Upper – lower limit) for all the variables.

4. The conclusion should be more concise and drawn on the basis of study reports.

Manuscript

1. Summarize the introductory part.

2. How come this trial is differing from reference number 9? – please justify.

3. Please describe about Psych – mind treatment and its benefits.

4. The authors fail to find and report the research gap in this session.

5. Include the clinical significance of this trial over clinicians, patients and researchers.

6. Present the manuscript as per CONSORT guidelines.

7. Include the study setting and study duration.

8. Include the reliability and validity of all the outcome measures used in the study.

9. Include the detail description of intervention and control group.

10. Include the method of sample size calculation with suitable reference.

11. Mention about the demographic details of the participants in the results section.

12. In the results section, please discuss about the treatment compliance rate, adverse effects and the number of dropouts.

13. Mention the reports with 95%CI (Upper – lower limit) for all the variables.

14. Report the effect size and MCID values of all the primary and secondary variables.

15. Summarize the discussion part and include the mechanism of interventions on different variables with recent references.

16. The conclusion should be more concise and drawn on the basis of study reports.

Reviewer #3: thanks alot for your response

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: Dr.Gopal Nambi

Reviewer #3: No

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

Goal Management Training and Psychoeducation / Mindfulness for Treatment of Executive Dysfunction in Parkinson’s disease: A Feasibility Pilot Trial.

PONE-D-21-08484R2

Dear Dr. Giguère-Rancourt,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Walid Kamal Abdelbasset, Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #3: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #3: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #3: No

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #3: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #3: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Dear authors,

Really appreciate your efforts for satisfactorily addressed my comments.

Really appreciate your efforts for satisfactorily addressed my comments.

Really appreciate your efforts for satisfactorily addressed my comments.

Reviewer #3: thanks alot for your respose

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: Gopal Nambi

Reviewer #3: No