PONE-D-23-21555

Effect of Ultrasound Therapy on Postpartum Uterine Involution: A Randomized Controlled Trial

PLOS ONE

Dear Dr. Niu,

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 Oct 09 2023 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.

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,

Ahmed Mohamed Maged, MD

Academic Editor

PLOS ONE

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Additional Editor Comments:

Please respond to all reviewers comments one by one clearly

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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: Partly

Reviewer #2: Partly

Reviewer #3: No

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

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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: No

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: The Ms completed by Niu Xiaoyu and co-authors mainly focused on studying the effect of Ultrasound Therapy on Postpartum Uterine Involution and the effects were principal evaluated via the duration of postpartum lochia. The data in Ms could partially support the conclusion that Ultrasound Therapy contributes to uterine involution and reduces the duration of postpartum lochia. Here I have some major concerns: 1, the functions of Ultrasound Therapy on Postpartum Uterine Involution have been reported several years ago by other groups, so pls showing your contributions detailly. 2, for the assay, you just chose one set-up parameters of ultrasound, can you tell us the underlying reasons. 3, the resolution ratio of the figures in Ms somehow is too low.

Reviewer #2: 1) Subjects

It is unclear what were the exclusion criteria. Were the following patients included or excluded?: "Patients with (1) placenta previa; (2) intrahepatic cholestasis of pregnancy; (3) triplets, twins, fetal macrosomia; (4) polyhydramnios; (5) history or signs of placental abruption; (6) severe pre-eclampsia; and (7) anticoagulant treatment, such as that for thrombocytopenia, for being included in the study."

2) Study design

The investigators blinded the treating physicians but not the participants. If all participants received standard of care treatment, what exactly was the rational for not blinding the participants to the allocated treatment (LIFUS or sham)? This should be stated and explained as this would be considered a significant study limitation.

3) Sample size calculation

Child birth and post partum haemorrhage are not uncommon phenomena and I would guess that the sample size of 176 is too small and the study is likely underpowered, even without doing a sample size calculation. It is unclear how sample size calculation was conducted and based on exactly what evidence. If it was based on a prior study, then please provide references and explanations. If there are no prior studies, then power calculation is irrelevant and the findings would be hypothesis generating.

4) The manuscript has multiple grammatical errors, typos, and inconsistent formatting. For example, variable font sizes within the text, inconsistent significant figure reporting, and grammatical errors and typos that can change or lead to misinterpretation of the text. Please follow the author guidelines for formatting the texts, figures, tables, legends, etc, and carefully proofread your manuscript in your revision.

Reviewer #3: A randomized sham-controlled clinical trial was conducted which aimed to describe lochia duration, postpartum symptoms, and uterine involution with the use of low-intensity focused ultrasound (LIFUS) compared to sham treatment. A statistically significant shorter lochia duration was observed in the intervention group compared to controls. Additionally, the height of the fundus differed significantly following the second and third treatment sessions.

Major revision:

Provide a comprehensive statistical methods section which includes all the statistical testing methods used for the analysis. Be specific.

Detailed revisions:

1- Express p-values more precisely, rather than p<0.05.

2- Abstract: For significant conclusions, state the direction of the effects.

3- Line 13 is unclear. “The doctors enroll subjects, one doctor assigns participants to subjects.”

4- Page 11, Line 5: Clarify the type of summary statistics that have been provided.

5- Page 11, Line 24: State the type of descriptive statistics that have been provided.

6- Page 12, Line 6: Clarify the type of summary statistics that have been provided.

7- Page 12: Sample size justification: The power calculation should include: (1) the estimated outcomes in each group; (2) the α (type I) error level; (3) the statistical power (or the β (type II) error level); (4) the target sample size, (5) for continuous outcomes, the standard deviation of the measurements, and (6) the statistical testing method which achieves the stated power.

8- Table 1: State the type of summary statistics provided. State the statistical testing methods used to estimate the p-values.

9- Page 12, Line 18: Provide a measure of dispersion for the median follow-up time. First and third quartiles or ranges would be appropriate.

10- Table 3: State the type of summary statistics provided.

11- Page 13, Line 2: The statistical term for average is mean.

12- Page 13, Line 12: A formal test of the interaction effect should be made. The interpretation of the results is confusing. Provide more clarity.

13- Table 5: Define “Group Plus.”

14- Table 6: State the type of summary statistics provided. Indicate the sample sizes: (1) overall, (2) for vaginal delivery, and (3) for cesarean section. State the statistical testing method(s) used to estimate the p-values.

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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.

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

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Attachments

Attachment

Submitted filename: comments.docx

PONE-D-23-21555R1Effect of Ultrasound Therapy on Postpartum Uterine Involution: A Randomized Controlled TrialPLOS ONE

Dear Dr. Niu,

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 2024 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,

Ahmed Mohamed Maged, MD

Academic Editor

PLOS ONE

Additional Editor Comments:

Please respond to all reviewers comments one by 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: (No Response)

**********

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: Partly

Reviewer #3: Partly

**********

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: No

**********

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: one important issue is the novelty of the study, just simple search the paper online, we can find many studies have done the similar job, for example, PMID: 35026964. and the introduction and discussion of paper is too simple.

Reviewer #3: Major revisions:

1- Section 2.3 Statistical analyses: Clarify the following statement. What does it mean to be "statistically described"? "The frequency of rank variables was statistically described, and the chi-square test was used to analyse the difference between the two groups."

2- The interaction effects in the GEE model, presented in table 5, do not appear to be correct. The interaction effect should be treatment (sham vs LIFUS) by session (time). The main effects are treatment and session. The full model would contain the following effects: Intercept, Treatment group, Session, and the interaction of Treatment group by Session. If the interaction effect is significant, provide an interpretation of the results, but do not test main effects because the tests for main effects are uninteresting in light of significant interactions. If interaction effects are non-significant, drop the interaction effects from the model and test the main effects. Determining which results to present when testing interactions is often a multi-step process.

Minor revisions:

1- The t-test begins with a lower case letter t.

2- Section 2.5 Sample Size: Indicate the statistical testing method which achieves 90% power. The power of 90% does not need to included twice.

3- Table 1: A) Rename the header "Full Sample" to "Total". B) Rename "Covariate" to "Variable".

4- Section 3.2: A) Indicate if the summary statistics are median and interquartile range.

B) Specify the differences of what measure between the two groups were analyzed using the Cox PH model... Cox models are typically used to predict time to an event.

6- The statistical analysis section fails to list and describe the use of the Kaplan-Meier method.

7- The following statement is vague. "Data were presented as the quantity (percention) deviation."

8- The values of the t, z and chi-square statistic can be dropped from the tables. The corresponding p-value is sufficient.

9- The standard statistical term for average is mean.

11- P-values never equal zero. Express small p-values as < 0.0001

12- Thoroughly proofread the manuscript. Many grammatical errors are present.

**********

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: 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.

Attachments

Attachment

Submitted filename: comments -20231121.docx

PONE-D-23-21555R2Effect of Ultrasound Therapy on Postpartum Uterine Involution: A Randomized Controlled TrialPLOS ONE

Dear Dr. Niu,

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 Feb 17 2024 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,

Ahmed Mohamed Maged, MD

Academic Editor

PLOS ONE

Additional Editor Comments:

Please respond to all reviewers comments

[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 #3: (No Response)

Reviewer #4: 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 #3: Yes

Reviewer #4: Yes

**********

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

Reviewer #3: No

Reviewer #4: 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 #3: Yes

Reviewer #4: 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 #3: No

Reviewer #4: 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 #3: Minor revisions:

2.4 Statistical Analysis section:

1- Line 22: The term t-test begins with a lower case t.

2- Line 24 still contains the vague phase of "statistically described". Please list the statistical methods to provide more clarity.

3- Line 25: The chi-square test was used to analyze the difference in what between the two groups?

4- Line 26 is unclear due to the repeated word "time. "The Cox proportional hazards model was used to analyze the time difference in time to lochia termination between the LIFUS and sham groups."

2.5 Sample Size

1- Line 10: Grammatical error: Replace "calculated" with "calculate".

2- Line 11: Explain the term "end time".

3- State the statistical testing method which achieves 90% power. Remove "90% power" at either line 13 or 16.

4- The value of the t-test can be removed from table 1 and replace "full sample" with "total".

3.2 Effectiveness.... section

5- Line 13: State precisely which differences are being compared. Same comment for the sentence that follows.

6- Lines 19-20: No statistical differences in what between the two groups?

7- Table 2: Kaplan-Meier curves are not compared with t-tests. Use an appropriate test for comparing Kaplan-Meier curves.

8- The standard statistical term for average is mean.

9- P-values never equal zero, express small p-values as p< 0.001, even in summary tables.

Reviewer #4: Please reformat the title using PICO pattern ( clarify the population included and outcomes

Add reference for sample size calculation

Add BMI to table 1

page 10 line 30 replace included by excluded

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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 #3: No

Reviewer #4: 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.

Effect of Low-intensity Focused Ultrasound Therapy on Postpartum Uterine Involution in Puerperal Women: A Randomized Controlled Trial

PONE-D-23-21555R3

Dear Dr. Niu,

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 will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at http://www.editorialmanager.com/pone/ and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, 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,

Ahmed Mohamed Maged, MD

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 #3: (No Response)

Reviewer #5: (No Response)

**********

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 #3: Yes

Reviewer #5: Yes

**********

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

Reviewer #3: Yes

Reviewer #5: 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 #3: Yes

Reviewer #5: 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 #3: Yes

Reviewer #5: Yes

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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 #3: Minor revisions:

1- Line 6: Grammatical error: Insert "the" between in and two.

2- Line 8: Remove the phase, "was statistically described" and provide more clarity in this sentence.

3- State the statistical testing method which achieves 90% power. Perhaps it is the t-test.

Reviewer #5: Overall, the paper is coherently developed. However, there are some suggestions.

Abstract:

- Line 23 – Keywords: - Capitalize the words.

- Replace the semicolon with a comma.

Introduction:

- Well structured.

- Line 7: add a comma after the word ‘’reduced’’.

Methods:

Study design:

- Line 16: Replace the word ‘’were’’ with the word ‘’was’’.

Discussion:

- Well structured.

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Reviewer #3: No

Reviewer #5: No

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