Vanderbilt Integrated Community TMS for Opioid Recovery (VICTORY): Study protocol for a randomized, controlled trial of non-invasive brain stimulation to reduce craving in people with opioid use disorder

PONE-D-26-38503

Dear Dr. Biernacki,

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.

As a Peer-Reviewed Funded Protocol, your submission is eligible for expedited review by in-house editors. Based on our evaluation, we are satisfied that your manuscript meets our publication criteria for Study Protocols, and is therefore considered to be suitable for publication subject to final journal 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.

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Kind regards,

Annesha Sil, Ph.D.

Staff Editor

PLOS One

Journal requirements:

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

2. Thank you for stating the following financial disclosure:

“This study is supported by a grant from the Tennessee Opioid Abatement Council to H.B.W. This trial sponsor has no authority over design, conduct, analysis or reporting of the trial. This work was also supported by National Institute on Drug Abuse K23DA059690 to H.B.W.”

Please state what role the funders took in the study.  If the funders had no role, please state: "The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript."

If this statement is not correct you must amend it as needed.

Please respond by return e-mail so that we can amend your financial disclosure and competing interests on your behalf.

3. Thank you for stating the following in the Competing Interests section:

“The authors have declared that no competing interests exist.”

We note that one or more of the authors are employed by a commercial company: “Synaptic PSYCH”

1. Please provide an amended Funding Statement declaring this commercial affiliation, as well as a statement regarding the Role of Funders in your study. If the funding organization did not play a role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript and only provided financial support in the form of authors' salaries and/or research materials, please review your statements relating to the author contributions, and ensure you have specifically and accurately indicated the role(s) that these authors had in your study. You can update author roles in the Author Contributions section of the online submission form.

Please also include the following statement within your amended Funding Statement.

“The funder provided support in the form of salaries for authors [insert relevant initials], but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.”

If your commercial affiliation did play a role in your study, please state and explain this role within your updated Funding Statement.

2. Please also provide an updated Competing Interests Statement declaring this commercial affiliation along with any other relevant declarations relating to employment, consultancy, patents, products in development, or marketed products, etc.

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Please include both an updated Funding Statement and Competing Interests Statement in your cover letter. We will change the online submission form on your behalf.

4. Original Protocol Contains Confidentiality Notice