Side 1 af 5. Appendix: Comments on SPIRIT statement:

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1 Side 1 af 5 Appendix: Comments on SPIRIT statement: Checklist: 1. Descriptive title: Study design, population, intervention and trial acronym are stated in the title (The efficacy of ACupuncture On Menopausal symptoms (ACOM study): protocol for a randomised study). 2. Trial registration: 2a: The study is registered on clinicaltrials.gov (NCT ). Brief title: The Efficacy of ACupuncture On Menopausal Symptoms (ACOM). 2b: All items from the Wolrd Health Organization Trial Registration Data set: All of this are found at ClinicalTrials.gov (NCT ). Scientific Title: (The efficacy of ACupuncture On Menopausal symptoms (ACOM study): protocol for a randomised study). Puplic title (Danish): Akupunktur og klimakterielle symptomer. 3. Date and version indentifier: This is stated at the top of the manuscript. 4. Sources and types of financial, material, and other supports: Funding: The Idella Foundation, University of Copenhagen and the Research Foundation of General Practice. Funding is stated in the abstract. 5. 5a: Names, affiliations, and roles of protocol contributors: Known by editor but on instruction for authors (manuscript-central) anonymous manuscript is required (blinded peer review). 5b: Name and contact information for the trial sponsor. Known by editor but on instruction for authors (manuscript-central) anonymous manuscript is required (blinded peer review). 5c: Role of study sponsor and funders Sponsor and funders has no role or authority in decision about design, collection, management, analyses, interpretation of data, writing of the report or decision about publication. 5d: Not applicable. 6. 6a: Research question, justification for undertaking the trial, summery of relevant studies, benefits and harms: Described under the introduction and study objective in the manuscript. 6b: Choice of comparators: The study is a randomised trial (cross-over) with 1:1 allocation to early (intervention) vs. late (control) acupuncture. In WMA theory acupuncture sham acupuncture is rather perceived as another, but less effective, form of therapeutic needling than an inert (placebo) treatment. Moreover, earlier studies have shown that sham acupuncture are associated with a moderately

2 Side 2 af 5 large nonspecific effect that might be larger compared to other inert placebo intervention. Thus, in this study we use a control group instead of a placebo group. This is described under intervention and setting section in the manuscript. 7. Objective: To evaluate the efficacy of a standardised acupuncture approach on women suffering from moderate to severe menopausal symptoms; primarily the efficacy on hot flushes by change from baseline to study week 6. This is stated under the objective section in the manuscript. 8. Trial design: The study is a randomised trial (cross-over) with 1:1 allocation to early (intervention) vs. late (control) acupuncture. This is stated under the method and intervention and setting section in the manuscript. 9. Study settings: The study will take place in Danish medical clinics. Reference to list of study sites can be provided by the author on request. 10. Inclusion and exclusion criteria: This is found in Table 1. Acupuncturist must be medical doctors educated in acupuncture by DSEA or DMAS or likewise. (Acupuncturist section in the manuscript) a: Intervention for each group: All study subjects will be offered to receive a weekly treatment in 5 consecutive weeks. Acupuncture points (CV-3, CV-4, LR-8, SP-6, SP-9). The needles will be inserted perpendicularly and rotated manual between finger and thumb for a few seconds to elicit de-qi. Needle retention time will be 10 minutes. Afterward the needle will be removed. Detailed information can be found under the intervention and setting section, needle and acupuncture points section in the manuscript and table 2 (acupuncture points). 11b: Discontinuing or modifying criteria: Intervention is discontinued if unexpected serious side effects occurs. Study subject will be excluded if situation listed in table 1 (exclusions criteria) occurs. 11c: Strategies to improve adherence and procedure to monitoring adherence: The control group (Group L) is offered treatment after week 6 and by this we hope to improve adherence. An information-meeting will be held with the acupuncturists and all are offered a 2.5-hour course concerning, study design and a review of the selected acupuncture points and techniques (Acupuncturists section in the manuscript). Acupuncturist will receive a certain amount of needles and must complete a documentation-form after each treatment. Unused needles and documentation-forms must be returned when the study is terminated. 11d: Concomitant care/intervention: No other interventions are permitted during the study period. Stated under exclusion criteria (table 1.) and the discussion section.

3 Side 3 af Primary and secondary outcome, measurement variable, analysis metric, method of aggregation, time point for each outcome, (measurement used, clinically meaningful reduction, registration of side effects) are stated under outcome/primary outcome/secondary outcome and adverse events. Main comparisons are stated under statistical analysis section in the manuscript. Primary outcome is collected at week six before cross-over. 13. Time schedule of enrolment, intervention, assessments and visits for participants: Trial flow/time schedule: Figure 1. Detailed descriptions are found under intervention and setting section plus outcome section in the manuscript. 14. Estimated number of participants needed: This is stated under power calculation section. 15. Recruitment: Stated under recruitment section in the manuscript a: Generation of allocation sequence: The allocation sequence is generated using the computer software SAS. Study subjects will be allocated by an independent person (independently of the project organization) after principal investigator has provided information about stratification-status. (Stated in the randomization section). 16b: Allocation concealment mechanism: The independent person who keeps the allocation-lists is contacted by . A PDF-file (with only study subjects trial-number and stratification-information) is completed by principal investigator and mailed to the independent person. The independent person returns the PDFfile with information of study subjects allocation status. 16c: Implementation: The allocation sequence is generated by a statistician and send directly to the independent person. Principal-investigator enrolls study subjects. Study subject will be allocated to group E or L by the independent person. Thereafter the principal-investigator refers the study subjects to the acupuncturist a: Blinding: The statisticians and outcome assessors will be blinded until all analyses have been completed. Study subjects and acupuncturists cannot be blinded. This is stated under the blinding section in the manuscript. 17b: Not relevant a: Data collection: Data will be collected by questionnaire (electronic) send by links in s. A screening-questionnaire, a baseline-questionnaire and outcome questionnaire (MSQ) are completed by study subject before randomization. Outcomes are assessed by the MenoScore Questionnaire (MSQ). The MSQ is developed and Rasch validated in an earlier validation study. This is stated under the outcome section in the manuscript. 18b: Participants retention, follow up and data on drop-outs:

4 Side 4 af 5 To improve adherence in the control group they are also offered treatment (after cross-over). Study subjects will receive the questionnaires (electronic) by mail. Study subjects not returning a completed questionnaire before scheduled time will receive a reminder (see outcome section in the manuscript). Drop outs will be contacted in order to clarify the causes of drop out (se outcome section in the manuscript). A logistic regression model will be used to investigate whether there are factors that influence dropout; these will then be added as adjustments to the linear mixed models in additional analyses so as to account for possible attrition. The primary analyses will be intention-to-treat analyses. Additionally, per-protocol analyses will be conducted where non-compliers will be omitted; four or more treatments are considered adequate adherence (see statistical analysis section in the manuscript). 19. Data management: Confidential data is safely stored in locked rums or in encrypted files. Only persons from the project organization can get access to data and only by permission from principal investigator. Approvals from the Danish Data Protection Agency (SUND ) are obtained and statistician and data-manager have signed a data-management contract in accordance to principles from the Danish Data Protection Agency (see ethics, regulatory authorities and registration section in manuscript) a: Statistical methods: See statistical analysis section in the manuscript. 20b: Additional analysis: See statistical analysis section in the manuscript. 20c: Definition of analysis population relating to protocol non-adherence and statistical method to handle missing data are described under statistical section in the manuscript. (A logistic regression model will be used to investigate whether there are factors that influence dropout; these will then be added as adjustments to the linear mixed models in additional analyses so as to account for possible attrition. The primary analyses will be intention-to-treat analyses. Additionally, per-protocol analyses will be conducted where non-compliers will be omitted; four or more treatments are considered adequate adherence). 21. Data monitoring: 21a: Composition of data monitoring committee: In Denmark GCP monitoring is not required in non-medication studies. Although, this study will follow the ICH-GCP guideline. The Danish Health Authority, Danish Data Protection Agency and Committees on Health Research Ethics are the authorities who are allowed to get access to all study material and can perform quality-control assessments on all study related procedures. 21b: No interim analysis will be conducted. 22. Harms: We expect no risk for the study subjects. Along with completing the MSQ at week 3, 6, 8, 11 and 26 the study subjects are asked if they have experienced any adverse events in relation to the treatments. Adverse events will be presented along with the outcomes (see adverse events section in the manuscript). 23. Auditing: Not applicable 24. Research ethics approval:

5 Side 5 af 5 See ethics, regulatory authorities and registration section in the manuscript. 25. Protocol amendments: The Danish Committees on Health Research Ethics must be informed of, and approve, any protocol amendments. Amendments will be updated on clinicaltrials.gov a: Informed consent: Principal investigator will obtain informed consent from study subjects (screening and informed consent section in the manuscript). 26b: not relevant. 27. Confidentiality: Data from potential and enrolled study subject will be collected, shared and maintained in accordance to the applicable principles of the Danish Data Protection Agency before, during and after the trial. See also item 19 and ethics, regulatory authorities and registration section in the manuscript. All data are stored (confidential/encrypted) in 10 years after the trial. 28. Declaration of interests: None. Funding are stated in the abstract. (ICMJE Disclosures is uploaded for all the authors at the DMJ manuscript-central). 29. Who will have access to the final trial dataset: Only persons from the project organization can get access to data and only by permission from principal investigator. Statistician and data-manager have signed a contractual agreement of how to handle data (which is in accordance to applicable laws). Please also refer to item Ancillary and post-trial care: Study subjects are not paid for their participation. All study subjects are covered by the Danish Patient Compensation-insurance (In Danish: Patienterstatnings-ordingen; Lov om klage- og erstatningsadgang inden for sundhedsvæsenet kap. 3), jf. patienterstatningens hjemmeside hvoraf det fremgår at forsøg på højere statslige uddannelsesinstitutioner, fx Panuminstituttet, er omfattet af erstatningsordningen: ( Principal investigator is employed at a University and the University is self-insured (selvforsikret). 31. Dissemination policy: 31a: Positive, negative and in-conclusive results will be published in relevant scientific journals and communicated to relevant instances. There is no publications restrictions. 31b: Vancouver principles for authorship are followed. Professional writers are not used. 31c: Information from protocol is public on clinicaltrials.gov. We plan to publish a protocolarticle. No other plans for public access to full protocol, participant-level dataset and statistical code are made at the present time. 32. Study subject will receive oral and written information plus the information study subjects rights and before you decide to participate written by the Danish Committees on Health Research Ethics. Study subjects must sign the informed consent before final enrolment. 33. Not relevant.

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