Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.

NCT07073846 | Recruiting Phase 4 DMC

• 1 other identifier: R-2025-3601-197
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this randomized clinical trial is to find out whether giving an intravenous lidocaine + dexmedetomidine combination (LIDEX) during laparoscopic bariatric surgery can lower post-operative pain, inflammation, and oxidative stress in adults with obesity. The main questions it aims to answer are:

• Pain control: Does LIDEX reduce pain 24 hours after surgery, as measured with the International Pain Outcomes Questionnaire (IPOQ)?
• Biomarkers: Does LIDEX lower blood levels of key inflammatory cytokines-interleukin-1 beta (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-10 (IL-10)-and oxidative-stress markers-malondialdehyde (MDA), the reduced/oxidized glutathione ratio (GSH/GSSG), superoxide dismutase (SOD), and catalase-compared with the individual drugs or saline placebo? Researchers will compare four groups: lidocaine alone, dexmedetomidine alone, LIDEX, and placebo (saline solution, a look-alike substance that contains no drug) to learn which approach works best. Participants will:
• Receive an intravenous infusion of their assigned study drug(s) during surgery.
• Provide three small blood samples (before surgery, immediately after, and three hours after).
• Complete a short pain questionnaire (IPOQ) 24 hours after surgery.

Conditions

Morbid Obesity Requiring Bariatric Surgery; Postoperative Pain; Postoperative Pain Management; Postoperative Analgesia; Postoperative Adjuvant Treatment; Postoperative Inflammatory Markers; Postoperative Inflammatory Response

Keywords

Bariatric Surgery; Laparoscopic Sleeve Gastrectomy; Laparoscopic Gastric Bypass; Pain Management; Lidocaine-Dexmedetomidine; Multimodal Analgesia; Inflammatory Cytokines; Oxidative Stress; Opioid-sparing Anesthesia; Enhanced Recovery (ERAS); Postoperarive Oxidative Stress

Outcome Measures

Primary Outcomes (1)

• Assessment of postoperative pain patient perception using the Spanish International Pain Outcomes Questionnaire (IPOQ). This questionnaire includes multiple items assessed on a numerical rating scale (NRS) from 0 to 10.

  * For most items (e.g., pain intensity, interference with activities, emotional impact), \*\*higher scores indicate worse outcomes\*\*. * For items such as pain relief and satisfaction, \*\*higher scores indicate better outcomes\*\*. Items include: * Highest and lowest pain intensity experienced since surgery * Proportion of time spent in pain * How pain limited physical activities (e.g., coughing, moving, walking) * Impact of pain on mood and emotional well-being * Adverse effects attributed to pain medication (e.g., nausea, dizziness) * Overall degree of pain relief obtained * Desire for additional analgesic treatment * Clarity and usefulness of information received about pain therapy * Extent of patient involvement in treatment decisions * Global satisfaction with pain management * Use of non-pharmacological methods for pain relief * Presence of pre-existing pain before hospital admission

  24 hours post-operative

Secondary Outcomes (2)

• Change in pro-inflammatory cytokine (IL-1β, IL-6, TNF-α) and anti -inflammatory IL-10 panel

  Day 0 - after anesthesia induction, end of surgery, and 3 hours postoperatively

• Change in oxidative-stress marker panel (MDA, GSH/GSSG ratio, SOD, catalase, neutrophil respiratory burst)

  Day 0 - after anesthesia induction, end of surgery, and 3 hours postoperatively

Study Arms (4)

Lidocaine Infusion (LID)

ACTIVE COMPARATOR

Intra-operative IV lidocaine 1 % at ≈ 1.5 mg·kg-¹·h-¹ (0.3 mL·kg-¹·h-¹). Infusion starts after induction and stops at skin closure; no post-operative infusion.

Drug: Intravenous Lidocaine infusion + Standard Anesthesia

Dexmedetomidine Infusion (DEX)

ACTIVE COMPARATOR

Intra-operative IV dexmedetomidine ≈ 0.3 µg·kg-¹·h-¹ (0.3 mL·kg-¹·h-¹) without loading dose, from induction to skin closure.

Drug: Intravenous Dexmedetomidine infusion + Standard Anesthesia

Lidocaine + Dexmedetomidine (LIDEX)

EXPERIMENTAL

Concurrent IV lidocaine 1 % (1.5 mg·kg-¹·h-¹) plus dexmedetomidine (0.3 µg·kg-¹·h-¹) in the same syringe, administered from induction to skin closure.

Drug: Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard Anesthesia

Saline Placebo

PLACEBO COMPARATOR

IV 0.9 % saline at 0.3 mL·kg-¹·h-¹ for the same duration as active arms; syringe identical in appearance.

Drug: 0.9 % Saline Placebo + Standard Anesthesia

Interventions

Intravenous Lidocaine infusion + Standard Anesthesia DRUG

Continuous IV infusion of lidocaine 1 % (10 mg mL-¹) at 0.3 mL kg-¹ h-¹ (≈ 1.5 mg kg-¹ h-¹) from induction of anaesthesia to skin closure. No loading bolus, no post-operative infusion.

Also known as: Xylocaine®, Lignocaine

Lidocaine Infusion (LID)

Intravenous Dexmedetomidine infusion + Standard Anesthesia DRUG

Continuous IV infusion of dexmedetomidine 1 µg mL-¹ at 0.3 mL kg-¹ h-¹ (≈ 0.3 µg kg-¹ h-¹) without loading dose, started after induction and stopped at skin closure. No post-operative infusion.

Also known as: Precedex®, Dexdor®, DEX

Dexmedetomidine Infusion (DEX)

Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard Anesthesia DRUG

Single syringe containing lidocaine 1 % (10 mg mL-¹) + dexmedetomidine 1 µg mL-¹, infused IV at 0.3 mL kg-¹ h-¹ (delivering ≈ 1.5 mg kg-¹ h-¹ lidocaine + 0.3 µg kg-¹ h-¹ dexmedetomidine) from induction to skin closure.

Also known as: LIDEX, Lidocaine-Dexmedetomidine cocktail, LID + DEX

Lidocaine + Dexmedetomidine (LIDEX)

0.9 % Saline Placebo + Standard Anesthesia DRUG

Volume-matched IV infusion of 0.9 % normal saline at 0.3 mL kg-¹ h-¹ for the same duration and through the same delivery line as active arms; identical syringe appearance.

Also known as: Normal Saline, Sodium Chloride 0.9 %, Serum Saline, 0.9 % NaCl, Isotonic saline, Physiologic saline, Saline solution (IV)

Saline Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18 - 60 years
• Male or female
• Elective laparoscopic bariatric surgery
• Post-operative pathway: post-anaesthesia care unit (PACU) followed by standard ward, with an expected in-hospital stay ≥ 24 h
• ASA physical-status II or III

You may not qualify if:

• Use of any loco-regional anaesthetic technique during the peri-operative period (transversus abdominis plane, paravertebral, spinal, epidural, erector spinae, or other abdominal wall blocks).
• Current substance abuse or illicit drug use.
• Previous abdominal surgery within the last 6 months.
• Known hypersensitivity or allergy to lidocaine, dexmedetomidine, amide local anaesthetics, or α₂-adrenergic agonists.
• Congestive heart failure, significant bradyarrhythmia, second- or third-degree atrio-ventricular block without pacemaker, severe hypotension, or current therapy with Class I/III anti-arrhythmic drugs.
• Estimated glomerular filtration rate (eGFR) \< 60 mL min-¹ 1.73 m-² (moderate-to-severe renal impairment).
• Severe hepatic impairment (Child-Pugh C).
• Pregnancy or lactation.
• Chronic opioid consumption \> 30 mg oral morphine equivalents per day for \> 4 weeks
• Active seizure disorder, myasthenia gravis, or other neurologic disease contraindicating lidocaine infusion.
• Patient cannot communicate
• Patient does not want to fill in the questionnaire
• Participation in another interventional study within the past 30 days.
• Intra-operative conversion to open surgery.
• Insufficient biological sample for biomarker analysis.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (2)

Hospital de Especialidades Centro Medico Nacional Siglo XXI

Mexico City, Mexico City, 06720, Mexico

RECRUITING

Unidad Médica de Alta Especialidad Hospital de Especialidades del Centro Médico Nacional Siglo XXI

Mexico City, Mexico City, 06720, Mexico

RECRUITING

Related Publications (32)

• Xie D, Wang F, Wen W, Li H. Postoperative analgesic effect of intravenous coinjection of lidocaine and dexmedetomidine in gynaecological surgery: a systematic review and meta-analysis. BMJ Open. 2024 Dec 11;14(12):e091904. doi: 10.1136/bmjopen-2024-091904.

  PMID: 39663167 RESULT

• Rekatsina M, Theodosopoulou P, Staikou C. Effects of Intravenous Dexmedetomidine Versus Lidocaine on Postoperative Pain, Analgesic Consumption and Functional Recovery After Abdominal Gynecological Surgery: A Randomized Placebo-controlled Double Blind Study. Pain Physician. 2021 Nov;24(7):E997-E1006.

  PMID: 34704710 RESULT

• Zhang Y, Zhou Y, Hu T, Tong X, He Y, Li X, Huang L, Fu Q. Dexmedetomidine reduces postoperative pain and speeds recovery after bariatric surgery: a meta-analysis of randomized controlled trials. Surg Obes Relat Dis. 2022 Jun;18(6):846-853. doi: 10.1016/j.soard.2022.03.002. Epub 2022 Mar 9.

  PMID: 35422388 RESULT

• de Oliveira CMB, Coelho LMG, Valadao JA, Moura ECR, da Silva AAM, de Lima RC, Brunialti MKC, Salomao R, da Cunha Leal P, Sakata RK. Assessment of the Effect of Perioperative Venous Lidocaine on the Intensity of Pain and IL-6 Concentration After Laparoscopic Gastroplasty. Obes Surg. 2020 Oct;30(10):3912-3918. doi: 10.1007/s11695-020-04748-1. Epub 2020 Jun 12.

  PMID: 32533519 RESULT

• Xu S, Hu S, Ju X, Li Y, Li Q, Wang S. Effects of intravenous lidocaine, dexmedetomidine, and their combination on IL-1, IL-6 and TNF-alpha in patients undergoing laparoscopic hysterectomy: a prospective, randomized controlled trial. BMC Anesthesiol. 2021 Jan 6;21(1):3. doi: 10.1186/s12871-020-01219-z.

  PMID: 33407156 RESULT

• Lai Y, Chen Q, Xiang C, Li G, Wei K. Comparison of the Effects of Dexmedetomidine and Lidocaine on Stress Response and Postoperative Delirium of Older Patients Undergoing Thoracoscopic Surgery: A Randomized Controlled Trial. Clin Interv Aging. 2023 Aug 3;18:1275-1283. doi: 10.2147/CIA.S419835. eCollection 2023.

  PMID: 37554513 RESULT

• Chen X, Chen Q, Qin Z, Alam A, Zhao H, West R, Liu X, Li J, Li X, Yi B, Ma D, Gu J. Dexmedetomidine Attenuates Inflammation in Elderly Patients Following Major Hepatobiliary and Pancreatic Surgery: A Randomized Clinical Trial. Clin Interv Aging. 2024 May 29;19:981-991. doi: 10.2147/CIA.S455987. eCollection 2024.

  PMID: 38827237 RESULT

• Ohta Y, Miyamoto K, Kawazoe Y, Yamamura H, Morimoto T. Effect of dexmedetomidine on inflammation in patients with sepsis requiring mechanical ventilation: a sub-analysis of a multicenter randomized clinical trial. Crit Care. 2020 Aug 10;24(1):493. doi: 10.1186/s13054-020-03207-8.

  PMID: 32778146 RESULT

• Zhang J, Wang Z, Wang Y, Zhou G, Li H. The effect of dexmedetomidine on inflammatory response of septic rats. BMC Anesthesiol. 2015 May 1;15:68. doi: 10.1186/s12871-015-0042-8.

  PMID: 25929655 RESULT

• Avci O, Taskiran AS, Gundogdu O. Dexmedetomidina, un agonista de α2, incrementa el efecto analgésico de la morfina y reduce el desarrollo de tolerancia a la morfina suprimiendo el estrés oxidativo y la vía de señalización de TNF/IL-1 en ratas. Rev Esp Anestesiol Reanim

  RESULT

• Ge DJ, Qi B, Tang G, Li JY. Intraoperative Dexmedetomidine Promotes Postoperative Analgesia and Recovery in Patients after Abdominal Hysterectomy: a Double-Blind, Randomized Clinical Trial. Sci Rep. 2016 Feb 23;6:21514. doi: 10.1038/srep21514.

  PMID: 26903197 RESULT

• Kaye AD, Chernobylsky DJ, Thakur P, Siddaiah H, Kaye RJ, Eng LK, Harbell MW, Lajaunie J, Cornett EM. Dexmedetomidine in Enhanced Recovery After Surgery (ERAS) Protocols for Postoperative Pain. Curr Pain Headache Rep. 2020 Apr 2;24(5):21. doi: 10.1007/s11916-020-00853-z.

  PMID: 32240402 RESULT

• Lai YC, Wang WT, Hung KC, Chen JY, Wu JY, Chang YJ, Lin CM, Chen IW. Impact of intravenous dexmedetomidine on postoperative gastrointestinal function recovery: an updated meta-analysis. Int J Surg. 2024 Mar 1;110(3):1744-1754. doi: 10.1097/JS9.0000000000000988.

  PMID: 38085848 RESULT

• Jessen Lundorf L, Korvenius Nedergaard H, Moller AM. Perioperative dexmedetomidine for acute pain after abdominal surgery in adults. Cochrane Database Syst Rev. 2016 Feb 18;2(2):CD010358. doi: 10.1002/14651858.CD010358.pub2.

  PMID: 26889627 RESULT

• Lin S, Jin P, Shao C, Lu W, Xiang Q, Jiang Z, Zhang Y, Bian J. Lidocaine attenuates lipopolysaccharide-induced inflammatory responses and protects against endotoxemia in mice by suppressing HIF1alpha-induced glycolysis. Int Immunopharmacol. 2020 Mar;80:106150. doi: 10.1016/j.intimp.2019.106150. Epub 2020 Jan 17.

  PMID: 31958741 RESULT

• Lee JM, Suh JK, Jeong JS, Cho SY, Kim DW. Antioxidant effect of lidocaine and procaine on reactive oxygen species-induced endothelial dysfunction in the rabbit abdominal aorta. Korean J Anesthesiol. 2010 Aug;59(2):104-10. doi: 10.4097/kjae.2010.59.2.104. Epub 2010 Aug 20.

  PMID: 20740215 RESULT

• Gunaydin B, Demiryurek AT. Interaction of lidocaine with reactive oxygen and nitrogen species. Eur J Anaesthesiol. 2001 Dec;18(12):816-22. doi: 10.1046/j.1365-2346.2001.00931.x.

  PMID: 11737181 RESULT

• Castro I, Carvalho P, Vale N, Monjardino T, Mourao J. Systemic Anti-Inflammatory Effects of Intravenous Lidocaine in Surgical Patients: A Systematic Review and Meta-Analysis. J Clin Med. 2023 May 31;12(11):3772. doi: 10.3390/jcm12113772.

  PMID: 37297968 RESULT

• Beaussier M, Delbos A, Maurice-Szamburski A, Ecoffey C, Mercadal L. Perioperative Use of Intravenous Lidocaine. Drugs. 2018 Aug;78(12):1229-1246. doi: 10.1007/s40265-018-0955-x.

  PMID: 30117019 RESULT

• MacGregor RR, Thorner RE, Wright DM. Lidocaine inhibits granulocyte adherence and prevents granulocyte delivery to inflammatory sites. Blood. 1980 Aug;56(2):203-9. No abstract available.

  PMID: 7397378 RESULT

• Paterson HM, Cotton S, Norrie J, Nimmo S, Foo I, Balfour A, Speake D, MacLennan G, Stoddart A, Innes K, Cameron S, Aucott L, McCormack K. The ALLEGRO trial: a placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery. Trials. 2022 Jan 28;23(1):84. doi: 10.1186/s13063-022-06021-5.

  PMID: 35090535 RESULT

• Ahn E, Kang H, Choi GJ, Park YH, Yang SY, Kim BG, Choi SW. Intravenous lidocaine for effective pain relief after a laparoscopic colectomy: a prospective, randomized, double-blind, placebo-controlled study. Int Surg. 2015 Mar;100(3):394-401. doi: 10.9738/INTSURG-D-14-00225.1.

  PMID: 25785316 RESULT

• Eipe N, Gupta S, Penning J. Intravenous lidocaine for acute pain: an evidence-based clinical update. BJA Educ. 2016 Sep 1;16(9):292-8.

  RESULT

• Baysal Z, Togrul T, Aksoy N, Cengiz M, Celik H, Boleken ME, Kaya M, Yavuz G. Evaluation of total oxidative and antioxidative status in pediatric patients undergoing laparoscopic surgery. J Pediatr Surg. 2009 Jul;44(7):1367-70. doi: 10.1016/j.jpedsurg.2008.11.031.

  PMID: 19573663 RESULT

• Tsuchiya M, Sato EF, Inoue M, Asada A. Open abdominal surgery increases intraoperative oxidative stress: can it be prevented? Anesth Analg. 2008 Dec;107(6):1946-52. doi: 10.1213/ane.0b013e318187c96b.

  PMID: 19020142 RESULT

• Mieszczanski P, Gorniewski G, Ziemianski P, Cylke R, Lisik W, Trzebicki J. Comparison between multimodal and intraoperative opioid free anesthesia for laparoscopic sleeve gastrectomy: a prospective, randomized study. Sci Rep. 2023 Aug 4;13(1):12677. doi: 10.1038/s41598-023-39856-2.

  PMID: 37542100 RESULT

• Ivascu R, Torsin LI, Hostiuc L, Nitipir C, Corneci D, Dutu M. The Surgical Stress Response and Anesthesia: A Narrative Review. J Clin Med. 2024 May 20;13(10):3017. doi: 10.3390/jcm13103017.

  PMID: 38792558 RESULT

• Torensma B, Hany M, Bakker MJS, van Velzen M, In 't Veld BA, Dahan A, Swank DJ. Correction to: Cross-Sectional E-survey on the Incidence of Pre- and Postoperative Chronic Pain in Bariatric Surgery. Obes Surg. 2023 Jan;33(1):211. doi: 10.1007/s11695-022-06395-0. No abstract available.

  PMID: 36463344 RESULT

• Iamaroon A, Tangwiwat S, Nivatpumin P, Lertwacha T, Rungmongkolsab P, Pangthipampai P. Risk Factors for Moderate to Severe Pain during the First 24 Hours after Laparoscopic Bariatric Surgery While Receiving Intravenous Patient-Controlled Analgesia. Anesthesiol Res Pract. 2019 Oct 3;2019:6593736. doi: 10.1155/2019/6593736. eCollection 2019.

  PMID: 31687018 RESULT

• Garduno-Lopez AL, Acosta Nava VM, Castro Garces L, Rascon-Martinez DM, Cuellar-Guzman LF, Flores-Villanueva ME, Villegas-Sotelo E, Carrillo-Torres O, Vilchis-Samano H, Calderon-Vidal M, Islas-Lagunas G, Richard Chapman C, Komann M, Meissner W, Baumbach P, Zaslansky R. Towards Better Perioperative Pain Management in Mexico: A Study in a Network of Hospitals Using Quality Improvement Methods from PAIN OUT. J Pain Res. 2021 Feb 15;14:415-430. doi: 10.2147/JPR.S282850. eCollection 2021.

  PMID: 33623424 RESULT

• De Oliveira GS Jr, Duncan K, Fitzgerald P, Nader A, Gould RW, McCarthy RJ. Systemic lidocaine to improve quality of recovery after laparoscopic bariatric surgery: a randomized double-blinded placebo-controlled trial. Obes Surg. 2014 Feb;24(2):212-8. doi: 10.1007/s11695-013-1077-x.

  PMID: 24036842 RESULT

• Tufanogullari B, White PF, Peixoto MP, Kianpour D, Lacour T, Griffin J, Skrivanek G, Macaluso A, Shah M, Provost DA. Dexmedetomidine infusion during laparoscopic bariatric surgery: the effect on recovery outcome variables. Anesth Analg. 2008 Jun;106(6):1741-8. doi: 10.1213/ane.0b013e318172c47c.

  PMID: 18499604 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Lidocaine; Dexmedetomidine; Fluocinonide; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluocinolone Acetonide; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Dulce María Rascón Martínez, Prof MD, MSc

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

• Arnulfo Calixto Flores, Prof MD, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dulce M Rascón Martínez, Prof MD, MSc

CONTACT

+ 52 55 5627 6900; dradulcerascon@gmail.com

Arnulfo Calixto Flores, Prof MD, PhD

CONTACT

+ 52 55 5627 6900; drrufo@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomisation codes are generated in 13 permuted blocks of eight by an independent investigator who is not involved in patient care or outcome assessment. The codes are printed, placed in sequentially numbered, opaque, sealed envelopes, and handed to the study nursing team. Immediately before anaesthetic induction, a research nurse opens the next envelope and communicates the allocation to a second nurse-preparer (also independent from clinical care). This nurse draws up a visually identical 50 mL syringe containing lidocaine, dexmedetomidine, the fixed-dose combination (LIDEX), or 0.9 % saline, according to the code. Each syringe is labelled only with the participant ID and infusion rate. Emergency unblinding is allowed solely for patient-safety reasons and must be reported immediately to the Data and Safety Monitoring Board.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Physician

Model Details: Randomized, quadruple-masked, four-arm parallel design.

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 18, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be available beginning 6 months after publication of the main study results in a peer-reviewed journal, and will remain available for up to 5 years after publication.
• Access Criteria: The de-identified individual participant data (IPD) that support the results of this study will be available to any interested researchers. The data will be publicly accessible through an open-access Zenodo repository following publication of the main study results. No request or approval will be necessary. All data will be anonymized and will not contain any information that could identify participants. Supporting documents such as the protocol, statistical analysis plan, and informed consent form will also be available in the same repository.

Locations

ME (2)