Otolaryngology Commons^™

Changes In The Transverse Dimension Of The Nasomaxillary Complex Following Rapid Palatal Expansion – A Post-Retention, Cbct Evaluation, Allison Schubert

Theses & Dissertations

Purpose: The purpose of this investigation was to evaluate the immediate and long-term effects of palatal expansion on the transverse dimension of the nasomaxillary complex.

Materials and Methods: Twenty-eight patients’ CBCTs were obtained at four time points: pre-expansion (T₁), post-expansion (T₂), pre-treatment (T₃), and middle or end of orthodontic treatment (T₄). The patients’ age, sex, cervical vertebral maturation stage, and the number of instructed expander turns were recorded. Measurements of the nasal floor, nasal passage, maxillary sinus, maxillary first molar mesiolingual cusp, maxillary first molar palatal cusp, maxillary first molar buccal cortical …

Taking Free Flap Surgery Abroad: A Collaborative Approach To A Complex Surgical Problem., Brian Swendseid, Md, Patrick Tassone, Md, Patrick Jean Gilles, Md, Magda Pavrette, Md, Matthew Stewart, Mercy Batatope, Donald Weed, Md, David Cognetti, Md, Adam J. Luginbuhl, Md, Joseph Curry, Md

Department of Otolaryngology - Head and Neck Surgery Faculty Papers

Accessibility to health care, especially complex surgical care, represents one of the major health care disparities in developing countries. While surgical teams may be willing to travel to these areas to help address these needs, there are many logistical and ethical dilemmas inherent in this pursuit. We reviewed our approach to the establishment of the team-based surgical outreach program, wherein we perform head and neck free tissue transfer surgery in Haiti. We describe the challenges encountered in the delivery of surgical care as well as ethical dilemmas relevant to surgical outreach trips, highlighting an approach reliant on strong local cooperation. …

Preservation Of Hearing And Facial Nerve Function With The Microsurgical Excision Of Large Vestibular Schwannomas: Experience With The Retrosigmoid Approach, Muhammad Shaheryar Ahmed Rajput, Ahmad Nawaz Ahmad, Asif Ali Arain, Muhammad Adeel, Syed Akram, Mohammad Sohail Awan, Muhammad Ehsan Bari

Section of Neurosurgery

Introduction: Vestibular schwannomas (VS) are the most common benign neoplasms of a cerebellopontine angle (CPA), which arise from the Schwann cells of the vestibulocochlear nerve. Eighty percent of CPA tumors are VS followed by meningioma as the second common mass lesion in this critical potential space. Treatment options range from watchful waiting with serial imaging studies to radiosurgery or a microsurgical excision or a combination of surgery and radiation therapy. The primary objective of the study was to assess hearing and facial nerve status before and after the surgery via the retrosigmoid approach.
Methods: The database of Aga Khan University …

Opioid-Prescribing Practices For Post-Operative Patients In Otolaryngology: A Multiphasic Quality Improvement Project In A Single Large Institution, Zachary Gandee, Sophia Dang, Alexander N. Duffy, Jonathan C. Li, Tanvi Rana, Brittany Gunville, Tingting Zhan, Elizabeth Cottrill, Md, David Cognetti, Md

Phase 1

Objectives:

In otolaryngology, postoperative pain management lacks evidence-based guidelines. We investigated opioid prescription and consumption for common procedures to develop prescribing guidelines at our institution.

Study Design:

Prospective, survey study.

Methods:

Patients who underwent surgery between July and September were given surveys upon discharge and at first follow-up visit. We assessed opioid usage and pain using the visual analog scale and opioid consumption throughout the postoperative period. Opioid prescriptions were converted to a standardized unit of 5 mg Oxycodone pills for reporting. Four procedures (transoral robotic surgery resection [TORS], sialendoscopy, parathyroidectomy/thyroidectomy, and parotidectomy) were selected for isolated analysis.

Results: …

The Impact Of Stuttering On Development Of Self-Identity, Relationships, And Quality Of Life In Women Who Stutter, Charn Nang, Deborah J. Hersh, Katie Milton, Su Re Lau

Research outputs 2014 to 2021

Purpose: The experiences of women who stutter have been underresearched. Clinicians have little guidance from the research literature on issues specific to women who stutter and are likely to have less clinical contact with this group than with men who stutter because of the higher prevalence of stuttering in men. This study explored the experiences of a small group of women who stutter with a particular focus on what the main current issues are and how gender may have influenced experiences with stuttering.

Method: This qualitative study involved recruitment of 9 women who stutter (aged 35-80 years) through a support …

Metformin Clinical Trial In Hpv+ And Hpv- Head And Neck Squamous Cell Carcinoma: Impact On Cancer Cell Apoptosis And Immune Infiltrate., Joseph M. Curry, Jennifer Johnson, Mehri Mollaee, Patrick Tassone, Dev Amin, Alexander Knops, Diana Whitaker Menezes, My Mahoney, Andrew P. South, Ulrich Rodeck, Tingting Zhan, Larry A. Harshyne, Nancy Philp, Adam J. Luginbuhl, David Cognetti, Madalina Tuluc, Ubaldo E. Martinez-Outshoorn, Md

Department of Otolaryngology - Head and Neck Surgery Faculty Papers

Background: Metformin, an oral anti-hyperglycemic drug which inhibits mitochondrial complex I and oxidative phosphorylation has been reported to correlate with improved outcomes in head and neck squamous cell carcinoma (HNSCC) and other cancers. This effect is postulated to occur through disruption of tumor-driven metabolic and immune dysregulation in the tumor microenvironment (TME). We report new findings on the impact of metformin on the tumor and immune elements of the TME from a clinical trial of metformin in HNSCC. Methods: Human papilloma virus-(HPV-) tobacco+ mucosal HNSCC samples (n = 12) were compared to HPV+ oropharyngeal squamous cell carcinoma (OPSCC) samples (n …

Metachronous Second Primary Malignancy In Head And Neck Cancer Patients: Is Five Years Of Follow-Up Sufficient?, Muhammad Adeel, Moghira Siddiqui

Section of Otolaryngology, Head & Neck Surgery

Objectives: The aim of this study was to determine the incidence and characteristics of second primary malignancy (SPM) in patients with head and neck squamous cell carcinoma treated at a tertiary care hospital.
Materials and methods: We retrospectively reviewed the medical records of 221 patients who underwent surgery with or without adjuvant treatment for head and neck cancer from 2000 to 2002. Data of age, sex, risk factors, sites of primary and SPM, TNM stage of primary tumor, incidence of SPM, and survival were collected from medical charts.
Results: Eighteen patients developed SPM during a median follow-up of 67 months, …

A Systematic Review Of Treating Recurrent Head And Neck Cancer: A Reintroduction Of Brachytherapy With Or Without Surgery., Julianna Rodin, Voichita Bar-Ad, David Cognetti, Joseph Curry, Jennifer Johnson, Chad Zender, Laura Doyle, David Kutler, Benjamin E. Leiby, William M. Keane, Adam J. Luginbuhl

Department of Otolaryngology - Head and Neck Surgery Faculty Papers

Purpose: To review brachytherapy use in recurrent head and neck carcinoma (RHNC) with focus on its efficacy and complication rates.

Material and methods: A literature search of PubMed, Ovid, Google Scholar, and Scopus was conducted from 1990 to 2017. Publications describing treatment of RHNC with brachytherapy with or without surgery were included. The focus of this review is on oncologic outcomes and the safety of brachytherapy in the recurrent setting.

Results: Thirty studies involving RHNC treatment with brachytherapy were reviewed. Brachytherapy as adjunctive treatment to surgical resection appears to be associated with an improved local regional control and overall survival, …

Management Of Enophthalmos From Silent Sinus Syndrome With A Customized Orbital Implant, Jason E. Cohn, Mofiyinfolu Sokoya, Mohammad Hararah, Sameep Kadakia, Yadranko Ducic

Otolaryngology (ENT) Resident Research

Background We describe the surgical treatment of silent sinus syndrome, a disease characterized by progressive enophthalmos and hypoglobus due to orbital floor collapse with opacification of the maxillary sinus, in the presence of chronic maxillary sinusitis.

Methods Case study of a 55-year-old male with persistent diplopia secondary to left-sided esotropia and enophthalmos from chronic maxillary sinusitis.

Results Two stage procedure to treat the sinonasal and orbital symptoms, which include endoscopic sinus surgery to treat the underlying the ostial obstruction along with decompression of maxillary sinus. Then, reconstruction of the orbital floor with a customized implant.

Conclusions Though the treatment of …

Holmium Laser For Endoscopic Treatment Of Benign Tracheal Stenosis, D J. Verret, Arneya Jategaonkar, Samuel Helman, Sameep Kadakia, Arash Bahrami, Eli Gordin, Yadranko Ducic

Otolaryngology (ENT) Resident Research

Introduction Laryngotracheal stenosis is a difficult problem with varied etiology and various treatment options. The holmium laser represents another tool for the treatment of benign tracheal stenosis.

Objectives To determine the utility of holmium laser treatment for benign tracheal stenosis with regards to safety and efficacy.

Methods This was a retrospective case study examining patients with benign tracheal stenosis from 1998–2016 who underwent holmium laser treatment. Determining the safety of this procedure was the primary goal, and complications were monitored as a surrogate of safety.

Results A total of 123 patients who underwent holmium laser treatment for benign tracheal stenosis …

Quality Of Life After Functional Endoscopic Sinus Surgery In Patients With Chronic Rhinosinusitis, Sadaf Qadeer, Shabbir Akhtar, Montasir Junaid, Muhammad Sohail Halim

Section of Otolaryngology, Head & Neck Surgery

Chronic Rhinosinusitis (CRS) is a group of disorders characterized by the inflammation of mucosa of the nasal passages and paranasal sinuses. It includes chronic rhinosinusitis with polyps, CRS without polyps and Allergic Fungal Sinusitis (AFS). This debilitating disease causes negative impact on quality of life (QOL) of patients. Functional endoscopic sinus surgery (FESS) is the mainstay of surgical treatment for patients and improves QOL of patients. This subjective assessment of QOL can be measured by disease specific questionnaires. SNOT-22 questionnaire is widely used and validated questionnaire for this purpose. Prospective study was done on 54 patients. Data were collected using …

Clinicopathological Prognostic Factors Of Oral Squamous Cell Carcinoma: An Experience Of A Tertiary Care Hospital, Muhammad Usman Shaikh, Ahmed Raheem Baksh, Sayed Akbar Abbas, Javeria Saeed, Salman Hashmi

Department of Pathology and Laboratory Medicine

Locoregional recurrence accounts for majority of the treatment failures in oral cancer patients. Current study aimed to determine the predictors of recurrence and survival in patients with biopsy proven Squamous Cell Carcinoma (SCC) of the oral cavity. This study included 88 patients of squamous cell carcinoma treated at our institution from 2007 till 2013. Primary intervention was surgery in all patients with radiation and chemotherapy in selected patients. Primary end point was locoregional recurrence, distant metastasis and death. Out of 88 patients, 23 (26.1%) patients developed locoregional recurrence and 6 (6.8%) patients developed distant metastasis. Overall survival rate was 77.3%. …

Cross-Departmental Educational Program On Complex Airway And Epistaxis Management, Adam Vasconcellos, Md, Meghan Crawley, Md, Michael Topf, Md, Ryan Gerritsen, Md, Dominick Gadaleta, Md, Joseph Spiegel, Md

House Staff Quality Improvement and Patient Safety Conference (2016-2019)

Internists, emergency medicine physicians, and intensivists routinely provide essential care for patients with complex airways (i.e. tracheostomy and laryngectomy) and patients with epistaxis. Any of these physicians may serve as first responder in a complex airway or epistaxis emergency situation. Therefore, a basic understanding of complex airway and epistaxis management is essential. The otolaryngology department aims to provide our colleagues with fundamental take-home points to improve crossdepartmental care of these patients.

Alcohol Drives Oxidation-Dependent Desensitization Of Airway Cilia Motility Responsiveness, Michael Price

Theses & Dissertations

Alcohol abuse, which can impair clearance of pathogens and debris from the airway, is associated with an increase in complications and a higher mortality rate during the progression of pneumonia. With prolonged alcohol exposure, mucociliary clearance (MCC), which depends on the coordinated beating of cilia, is dysfunctional. Effective MCC relies on cAMP-dependent protein kinase (PKA) activation of ciliary beat frequency (CBF). PKA activation and stimulation of CBF are blunted with chronic exposure to alcohol. This phenomenon is known as alcohol-induced ciliary dysfunction (AICD). Previous studies have shown that concomitant feeding of mice with alcohol and antioxidants prevents AICD, suggesting a …

Melodic Contour Identification And Speech Recognition By School-Aged Children, Michael P. Morikawa

Dissertations, 2014-2019

Using the Sung Speech Corpus (SSC), which encompasses a single database that contains musical pitch, timbre variations and speech information in identification tasks, the current study aimed to explore the development of normal-hearing children’s ability to use the pitch and timbre cues. Thirteen normal hearing children were recruited for the study ages ranging from 7 to 16 years old. Participants were separated into two separate groups: Younger (7-9) and Older (10-16). Musical Experience was taken into account as well. The Angel Sound ™ program was utilized for testing which was adopted from previous studies, most recently Crew, Galvin, and Fu …

Jejunal Intussusception: A Rare Manifestation Of A Primary Thyroid Non-Hodgkin Lymphoma, Abu Baker Sheikh, Usman Tariq, Marvi M. Bukhari, Sana Shah, Rao M. Afzal, Abdul Ahad E. Shaikh, Nimra Nadeem

Medical College Documents

Primary thyroid lymphoma (PTL) is an uncommon malignancy of the thyroid gland, with most lymphomas of the thyroid being almost exclusively of the non-Hodgkin's B cell variety. PTL requires a prompt diagnosis because of its ability to cause progressive compression symptoms, and its unusual presentation can make the diagnosis very challenging. Herein, we present a case of PTL in a young woman with an uncommon initial presentation and discuss the complications she faced during the surgery, as well as postoperatively, due to the compression of the trachea by the thyroid mass.

Knockout Of Pannexin-1 Induces Hearing Loss, Jin Chen, Chun Liang, Liang Zong, Yan Zhu, Hong-Bo Zhao

Otolaryngology--Head & Neck Surgery Faculty Publications

Mutations of gap junction connexin genes induce a high incidence of nonsyndromic hearing loss. Pannexin genes also encode gap junctional proteins in vertebrates. Recent studies demonstrated that Pannexin-1 (Panx1) deficiency in mice and mutation in humans are also associated with hearing loss. So far, several Panx1 knockout (KO) mouse lines were established. In general, these Panx1 KO mouse lines demonstrate consistent phenotypes in most aspects, including hearing loss. However, a recent study reported that a Panx1 KO mouse line, which was created by Genentech Inc., had no hearing loss as measured by the auditory brainstem response (ABR) threshold at low-frequency …

Unusual Presentation Of Differentiated Thyroid Cancer Metastasis, Haissan Iftikhar, Mubasher Ikram, Adnan Yar Muhammad, Karim Rizwan Nathani

Section of Otolaryngology, Head & Neck Surgery

Introduction  The rates of thyroid cancers are on a rise, especially well-differentiated thyroid cancers. This could be partly due to newer diagnostic modalities, like high-resolution ultrasound, that can pick up smaller lesions. Differentiated thyroid cancers with distant metastases are not common, and even rarer is the initial presentation with complaints not related to the neck.

Objectives  The objective of this series was to study and report the unusual cases of patients with differentiated thyroid cancer with distant metastasis. There is a lack of data in the literature on these cases, and due to the rarity of such metastases, no definite …

Frequency Of Cervical Nodal Metastasis In Early Stage Squamous Cell Carcinoma Of The Tongue, Sadaf Qadeer Ahmed, Montasir Junaid, Mohammad Sohail Awan, Maliha Kazi, Hareem Usman Khan, Sohail Haleem

Section of Otolaryngology, Head & Neck Surgery

ntroduction Oral cavity carcinoma is an aggressive tumor, with the tongue being one of the most common subsites of involvement. Surgery is a gold standard method of dealing with advanced-stage tumors. However, for early-stage carcinomas of the tongue, the management remains controversial. Several studies have indicated that early-stage cancers have a high chance of occult cervical node metastasis, which, if left untreated, can greatly affect the prognosis. Certain parameters can help identify patients with occult cervical node metastases, and can avoid unnecessary neck dissection in node negative patients. Tumor thickness is one such objective parameter. Objective To estimate the frequency …

Management Of Deep Space Infections Of The Neck, Emil Mărginean, Sargarovschi Egor, Ciprian Venter, Alina Pantiș, Oana Vălenaș, Ildiko Sorban, Maria Domuța, Cristian Bălălău, Razvan V. Scaunasu Md, Bogdan Popescu

Journal of Mind and Medical Sciences

Infections of the deep neck spaces often present a clinical challenge for the ENT surgeon. Management of these complex suppurations of the neck requires in fact a multidisciplinary approach due to possible complications like mediastinitis, septic shock and MSOF, life threatening bleeding and ICU management. The spread of infection from the primary site to other regions is possible through the lymphatic, arterial and venous vessels, or directly along the fasciae. There are several classifications for the etiology, pathogenic mechanism and site of evolution, the most frequently encountered clinical forms being peritonsillar abscess, retropharyngeal abscess, lateropharyngeal abscess, and the deep cervical …

Phosphaturic Mesenchymal Tumor Of The Nasal Cavity: Clinicopathologic Correlation Is Essential For Diagnosis, Aidan Kerr, Ryan Rimmer, Marc Rosen, James J. Evans, Madalina Tuluc, Stacey K. Mardekian

Department of Pathology, Anatomy, and Cell Biology Faculty Papers

Phosphaturic mesenchymal tumor (PMT) is a rare neoplasm in which the tumor cells produce fibroblast growth factor 23 (FGF23), leading to oncogenic osteomalacia and thus a distinct clinical presentation. However, the pathologic findings of PMT are often non-specific and variable, especially in tumors occurring in the head and neck. We present a case of a 66-year-old female who presented with osteomalacia-related symptoms and was found to have a nasal cavity mass. Histopathologic examination was suggestive of PMT but certain characteristic features were lacking, requiring confirmation of the diagnosis by chromogenic in situ hybridization (CISH) assay for FGF23 mRNA. The patient's …

Comparison Of New Metrics For Assessment Of Risks Of Occupational Noise, Wisam Al-Dayyeni, Jun Qin

Journal of Applied Sciences and Arts

Noise induced hearing loss (NIHL) is one of the most common occupational related health problems worldwide. Exposure to excessive noise is the major avoidable cause of permanent hearing loss. The conventional metrics for noise evaluation cannot accurately assess the exposure risks to high-level complex noise, which commonly occurs in many industrial and military fields. Recently, we have developed two advanced models, an adaptive weighting (F-weighting) and a complex velocity level (CVL) auditory fatigue model, to evaluate the risks of occupational noise. In this study, we compared performances of five noise assessment metrics, including F-weighted sound pressure level (SPL) LFeq, CVL …

Open Access: Is There A Predator At The Door?, R. Chandra, E. W. Fisher, T. M. Jones, D. W. Kennedy, D. H. Kraus, J. H. Krouse, M. J. Link, L. R. Lustig, B. W. O'Malley, R. Youngs, +8 Additional Authors

Journal Articles

No abstract provided.

Thyroseq V3 Molecular Profiling For Tailoring The Surgical Management Of Hürthle Cell Neoplasms., S. Pearlstein, A. H. Lahouti, E. Opher, Y. E. Nikiforov, D. B. Kuriloff

Journal Articles

Hürthle cell predominant thyroid nodules often confound the diagnostic utility of fine needle aspiration biopsy (FNAB) with cytology often interpreted as a Hürthle cell lesion with an indeterminate risk of malignancy, Bethesda category (BC) III or IV. Molecular diagnostics for Hürthle cell predominant nodules has also been disappointing in further defining the risk of malignancy. We present a case of a slowly enlarging nodule within a goiter initially reported as benign on FNAB, BC II but on subsequent FNAB suspicious for a Hürthle cell neoplasm, BC IV. The patient had initially requested a diagnostic lobectomy for a definitive diagnosis despite …

Isolated Inferior Rectus Muscle Entrapment Following Endoscopic Sinus Surgery, Scott Shapiro, Jamie L. Schaefer, Sumeet Gupta, John Nguyen, Brian Kellerymeyer

Faculty & Staff Scholarship

Orbital complications are known risks of endoscopic sinus surgery (ESS). The lamina papyracea and medial rectus muscle are the most commonly injured structures during ESS. Inferior rectus injury is more rare, with only one reported case of isolated inferior rectus injury in the literature. Guidelines for managing ESS-induced inferior rectus injury do not exist, and delayed intervention and management of adjacent sinuses may affect long-term outcomes such as persistent diplopia and disfigurement. In this report, we present a case of a 67-year-old man with diplopia due to isolated left inferior rectus muscle entrapment and injury from violation of the orbital …

Remarkable Presentation: Anaplastic Thyroid Carcinoma Arising From Chronic Hyperthyroidism, Habib G. Zalzal, Jeffson Chung, Jessica A. Perini

Faculty & Staff Scholarship

Background. Undifferentiated anaplastic carcinoma rarely develops from chronic hyperthyroidism. Although acute hyperthy- roidism can develop prior to anaplastic transformation, chronic hyperthyroidism was thought to be a protective measure against thyroid malignancy. Methods. A 79-year-old female presented acutely to the hospital with dyspnea. She had been taking methimazole for chronic hyperthyroidism due to toxic thyroid nodules, previously biopsied as benign. Upon admission, imaging showed tracheal compression, requiring a total thyroidectomy with tracheostomy for airway management. Results. Pathology demonstrated undifferentiated anaplastic thyroid carcinoma. The patient passed away shortly after hospital discharge. Despite treatment with methimazole for many years, abrupt enlargement of her …

Tracheocutaneous Sinus Following Tracheocutaneous Fistula Repair: Management Strategies In A Pediatric Patient, Adam Bender-Heine, Habib G. Zalzal, Nainika Nanda, Hassan Ramadan

Faculty & Staff Scholarship

Objective. To present a rare case of a pediatric tracheocutaneous sinus years after repair of a tracheocutaneous fistula and to review management strategies. Background. A tracheocutaneous fistula is a common sequela of pediatric tracheostomy and can occur in as many as one in three pediatric patients. There is debate in the literature regarding optimal surgical management. Case Presentation. An 8-year-old girl presented to the emergency department with swelling and erythema over the anterior neck. Clinical exam and diagnostic imaging revealed an underlying tracheocutaneous sinus. Discussion. Complications following pediatric tracheostomy are common and range in complexity from stomal granulation to tracheocutaneous …

Palatine Tonsil Stenting Of The Airway As Determined By Drug-Induced Sleep Endoscopy, Habib G. Zalzal, Steven Coutras

Faculty & Staff Scholarship

Objective. To demonstrate lateral pharyngeal wall collapse and increased apnea-hypopnea index in a child posttonsillectomy. Background. Some children have worsening of their sleep symptoms after tonsillectomy for obstructive sleep apnea. This case report demonstrates an open airway on drug-induced sleep endoscopy (DISE) in a child with tonsillar hypertrophy followed by more pronounced airway obstruction related to lateral pharyngeal wall collapse after tonsillectomy. Case Presentation. A 7-year- old boy presented with obstructive sleep apnea and underwent workup with DISE. Following adenotonsillectomy and subsequent lingual tonsillectomy with epiglottopexy, the patient’s sleep apnea symptoms and polysomnogram results worsened. Subsequent DISE showed a more …

International Consensus (Icon) On Treatment Of Sudden Sensorineural Hearing Loss, M. Marx, E. Younes, S. S. Chandrasekhar, J. Ito, S. Plontke, S. O'Leary, O. Sterkers

Journal Articles

© 2018 Elsevier Masson SAS Sudden sensorineural hearing loss (SSNHL) is a common and alarming symptom that often prompts an urgent visit to an ENT specialist. Treatment of SSNHL remains one of the most problematic issues for contemporary otorhinolaryngology: although many meta-analyses and national guidelines have been issued, management is not standardized in terms of medical treatment, and duration and route of administration. We present several methodological suggestions for the study of treatments for SSNHL. These were developed from the existing level of evidence of the main treatments used in SSNHL by experts who convened at the IFOS 2017 ENT …

Efficacy Of A Non-Invasive Middle Ear Aeration Device In Children With Recurrent Otitis Media: A Randomized Controlled Trial Protocol, T. Tham, L. Rahman, P. Costantino

Journal Articles

© 2018 The Authors Acute otitis media (AOM) represents a significant disease burden in the pediatric population. Besides vaccinations, there are no robust measures of reducing incidence of AOM in this age-group. This is a randomized controlled clinical trial evaluating the efficacy of a non-invasive middle ear aeration device, the EarPopper device (EP). We aim to investigate the reduction of episodes AOM in children with recurrent otitis media. The control arm will be observational. The intervention arm will have the EP used. The primary endpoint is incidence of AOM. The secondary endpoints are hazard ratio of time to AOM, proportion …