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103 citation(s) found for "Ayoub, M".

The Role of Cardiovascular Imaging in the Diagnosis of Athlete’s Heart: Navigating the Shades of Grey
Ali, Nima Baba , Esfahani, Sogol Attaripour , Scalia, Isabel G. , Farina, Juan M. , Pereyra, Milagros , Barry, Timothy , Lester, Steven J., Alsidawi, Said , Steidley, D. Eric , Ayoub, Chadi , Palermi, Stefano , Arsanjani, Reza , Baba Ali, Nima , Attaripour Esfahani, Sogol, Steidley, David E, Arsanjani, Reza , Farina, Juan M , Pereyra, Milagros , Alsidawi, Said , Scalia, Isabel G

Journal of Imaging | September 16, 2024 | Volume: 10 | Issue: 9 | Pages: 230

10.3390/jimaging10090230 | PMID 39330450 Get It

Athlete’s heart (AH) represents the heart’s remarkable ability to adapt structurally and functionally to prolonged and intensive athletic training. Characterized by increased left ventricular (LV) wall thickness, enlarged cardiac chambers, and augmented cardiac mass, AH typically maintains or enhances systolic and diastolic functions. Despite the positive health implications, these adaptations can obscure the difference between benign physiological changes and early manifestations of cardiac pathologies such as dilated cardiomyopathy (DCM), hypertrophic cardiomyopathy (HCM), and arrhythmogenic cardiomyopathy (ACM). This article reviews the imaging characteristics of AH across various modalities, emphasizing echocardiography, cardiac magnetic resonance (CMR), and cardiac computed tomography as primary tools for evaluating cardiac function and distinguishing physiological adaptations from pathological conditions. The findings highlight the need for precise diagnostic criteria and advanced imaging techniques to ensure accurate differentiation, preventing misdiagnosis and its associated risks, such as sudden cardiac death (SCD). Understanding these adaptations and employing the appropriate imaging methods are crucial for athletes’ effective management and health optimization.
Impact of transcatheter edge to edge repair in functional mitral regurgitation and cardiac resynchronization‐therapy nonresponders
Abraham, Bishoy , Suppah, Mustafa , Elbanna, Mostafa , Kaldas, Sara, Fortuin, F. David , Sweeney, John , Ayoub, Chadi , Sell-Dottin, Kristen, Megaly, Michael S. , Alsidawi, Said , Alkhouli, Mohamad , Sell‐Dottin, Kristen , Chao, Chieh‐Ju , Arsanjani, Reza

Catheterization and Cardiovascular Interventions | August 15, 2024 | Volume: 104 | Issue: 4 | Pages: 829-836

10.1002/ccd.31190 | PMID 39146522 Get It

AbstractBackgroundDespite optimal medical therapy and cardiac resynchronization therapy (CRT), significant functional mitral regurgitation (MR) persisted in 30% of the patients and labeled as CRT nonresponders.AimsWe sought to study the impact of transcatheter edge‐to‐edge repair (TEER) in patients with symptomatic grade III and IV functional MR despite CRT.MethodsA retrospective analysis was conducted of all patients who had prior CRT for at least 6 months and underwent TEER for significant residual functional MR (grade ≥3) and symptomatic heart failure (HF) at our institution. The primary outcomes were the change in New York Heart Association classification (NYHA), MR grade, echo parameters, and NT‐ProBNP from baseline to 1‐year post‐procedure.ResultsA total of 28 patients were identified, mean age of 73 ± 6.7 years and 89% males. Procedure success was achieved in all patients. At 1‐year follow‐up, patients had lower MR grade (median 2, IQR 1 [1,2] vs. 4, IQR 1 [3,4]; p < 0.001), NYHA class (median 2, IQR 1 [2,3] vs. 3, IQR 1 [3,4]; p < 0.001), and NT‐ProBNP (7658 ± 11322 vs. 3760 ± 4431; p = 0.035) compared to before the TEER procedure. The left ventricular end‐diastolic volume (255 ± 59 vs. 244 ± 66 mm; p = 0.016) and the right ventricular systolic pressure (52 ± 14 mmHg vs. 37 ± 13 mmHg, <0.001) decreased.ConclusionPatients who remain symptomatic after CRT with severe functional MR had improved functional status and MR grade at 1‐year following TEER. There was a signal toward reverse remodeling.
High Lp(a) levels are a potential risk factor for aortic valve interventions in patients with bicuspid aortic valve
Farina, J M, Abbas, Moncef, Mahmoud, Ahmed K., Lester, S.C., Barry, Timothy, Marcotte, F, Pereyra, Milagros , Pereyra, Milagros , Arsanjani, Reza , Kamel, M A, Abbas, M T, Scalia, Isabel G. , Mahmoud, Ahmed , Ali, N Baba, Ayoub, C, Sell‐Dottin, Kristen , Alsidawi, Said , Lester, S, Majdalany, David S

European Journal of Preventive Cardiology | June 14, 2024 | Volume: 31 | Issue: Supplement_1 | Pages: No page available

10.1093/eurjpc/zwae175.359 Get It

Abstract Background Bicuspid aortic valve (BAv) is associated with increased oxidative stress and inflammation, resulting in valve fibrosis, calcification, and ultimately early degenerative valve disease, often necessitating premature aortic valve intervention. In recent years, growing evidence has been published supporting the role of lipoprotein(a) [Lp(a)], an important carrier of oxidized phospholipids, in the development of aortic valve disease in the general population. However, the specific influence of Lp(a) levels in patients with BAv remains to be firmly established. Purpose To assess the role of Lp(a) levels in the development of aortic valve disease and the necessity for aortic valve interventions among individuals with BAv. Methods This retrospective multicenter study encompassed consecutive patients diagnosed with BAv from January 1997 to December 2022, all of whom had undergone serum Lp(a) measurement. This study evaluated the association between Lp(a) concentrations and the occurrence of aortic valve interventions. A cutoff point of ≥30 mg/dl for high Lp(a) levels was established. Binary logistic regression was utilized to calculate the odds ratio (OR) for an aortic intervention according to high versus low Lp(a) levels. Additionally, Kaplan Meier curves were employed to estimate the cumulative requirement for an aortic valve replacement based on Lp(a) concentrations. Results A total of 452 patients with BAv and a Lp(a) measurement were included in the study, with a mean age of 37.2 ±10.5 years at the time of BAv diagnosis, with 71.2% being male. Among these, 101 (22.3%) patients underwent an aortic valve replacement. In 72 cases (71.3%) aortic stenosis was the primary indication for intervention, while aortic regurgitation accounted for 29 cases (28.7%). The presence of elevated Lp(a) levels (≥30 mg/dl) demonstrated a significant association with the requirement for an aortic valve intervention (OR 2.2, 95%CI 1.4-3.6, p&lt;0.001) in both the regression analysis and using the Kaplan-Meier estimator (Figure). High Lp(a) concentrations posed a risk factor for aortic valve replacements regardless of whether the primary indication for intervention was significant stenosis (OR 1.8, 95%CI 1.1-3.1, p=0.028) or regurgitation (OR 2.5, 95%CI 1.2-5.4, p=0.018). Conclusion Increased concentrations of Lp(a) may influence the clinical trajectory of patients with a BAv and may be a significant risk factor for aortic valve replacement, irrespective of the primary indication for intervention. Further investigations will be critical in unveiling the precise pathological mechanisms of Lp(a) in BAv. Confirming whether reducing Lp(a) levels could slow the progression of aortic disease in this demographic requires further exploration. Kaplan-Meier estimator.
Validating a Computable Phenotype for Nephrotic Syndrome in Children and Adults Using PCORnet Data
Marchel, Dorota , Tran, Cheryl L. , Greco, Jessica , Denburg, Michelle , Oliverio, Andrea L. , Ayoub, Isabelle , Almaani, Salem , Gipson, Debbie S , Mariani, Laura H.

Journal of the American Society of Nephrology | May 17, 2024 | Volume: 31 | Issue: 10S | Pages: 582-582

10.1681/asn.20203110s1582b Get It

The role of serum lipoprotein(a) levels in bioprosthetic aortic valve degeneration
Fariña, Juliana, Roarke, M., Barry, Timothy, Sweeney, John P., Fortuin, David, Lester, Steven J., Oh, Jae K. , Marcotte, F, Pereyra, Milagros , Pereyra, Milagros , Farina, J, Chao, Chieh‐Ju , Said, E, Alsidawi, Said , Sell‐Dottin, Kristen , Ayoub, C, Arsanjani, Reza

European Heart Journal | November 11, 2023 | Volume: 44 | Issue: Supplement_2 | Pages: No page available

10.1093/eurheartj/ehad655.1616 Get It

Abstract Introduction Lipoprotein(a) [Lp(a)] is associated with an increased incidence of aortic stenosis. Bioprosthetic aortic valve degeneration and native aortic stenosis share similar pathological mechanisms. Evidence regarding the role of serum Lp(a) concentrations in bioprosthetic aortic valve degeneration is lacking. Purpose To evaluate the association between serum Lp(a) concentrations and bioprosthetic aortic valve degeneration. Methods In this retrospective multicenter study, consecutive patients who underwent a bioprosthetic aortic valve replacement between Jan-2010 and Dec-2020 and had a preoperatory serum Lp(a) measurement were included. A baseline transthoracic echocardiography (TTE) was performed following the aortic valve replacement and a follow-up TTE was performed at least 24 months after the baseline study to determine the presence of bioprosthetic valve degeneration. Significant degeneration was defined as: (a) an increase &gt;10 mmHg in mean bioprosthetic aortic valve gradient from baseline status + a decrease in effective orifice area + a decrease in Doppler velocity index + exclusion of clinically thrombotic leaflet thickening, OR (b) new moderate or severe prosthetic aortic regurgitation (if the main component was periprosthetic, then it was not considered). Lp(a) concentrations were compared between patients with and without degeneration and regression analysis was conducted to investigate the association between bioprosthetic valve degeneration and Lp(a) levels. Results In total, 211 cases were included (mean age 74.1 ±9.4 years, 72.0% males, 29.9% transcatheter aortic valve replacements) (Figure 1). Median time between baseline and follow-up TTE was 5.0 (IQR 3.7) years. Bioprostheses degeneration was observed in 33 (15.6%) patients at follow-up. Median serum levels of Lp(a) were significantly higher in the patients affected by degeneration versus non-affected cases (50.0 vs 15.7 mg/dl, p=0.003). In the regression analysis, high Lp(a) levels (≥30 mg/dl) were associated with degeneration both in a univariate analysis (OR 4.8, 95%CI 2.2-10.9, p&lt;0.001) and multivariate analysis adjusted by other risk factors for bioprostheses degeneration (age, sex, hypertension, smoking, patient prosthesis mismatch, creatinine levels, and body surface area) (OR 5.2, 95%CI 2.1-12.8, p&lt;0.001). Conclusion Serum Lp(a) concentrations seem to be a risk factor for bioprosthetic aortic valve degeneration (Figure 2). There is an increasing need to accurately predict bioprosthetic aortic valve degeneration and to develop novel methods and treatments to increase their durability. Prospective studies are needed to confirm these findings and to investigate whether lowering Lp(a) could slow bioprostheses degradation.Population characteristicsLp(a) and bioprostheses degeneration
Artificial Intelligence-Based Prediction of Cardiovascular Diseases from Chest Radiography
Farina, Juan M. , Pereyra, Milagros , Mahmoud, Ahmed , Scalia, Isabel G. , Abbas, Mohammed Tiseer , Barry, Timothy , Ayoub, Chadi , Banerjee, Imon , Arsanjani, Reza , Barry, Timothy , Arsanjani, Reza , Banerjee, Imon , Farina, Juan M , Pereyra, Milagros , Mahmoud, Ahmed K , Scalia, Isabel G , Abbas, Mohammed Tiseer , Chao, Chieh‐Ju

Journal of Imaging | October 27, 2023 | Volume: 9 | Issue: 11 | Pages: 236

10.3390/jimaging9110236 | PMID 37998083 Get It

Chest radiography (CXR) is the most frequently performed radiological test worldwide because of its wide availability, non-invasive nature, and low cost. The ability of CXR to diagnose cardiovascular diseases, give insight into cardiac function, and predict cardiovascular events is often underutilized, not clearly understood, and affected by inter- and intra-observer variability. Therefore, more sophisticated tests are generally needed to assess cardiovascular diseases. Considering the sustained increase in the incidence of cardiovascular diseases, it is critical to find accessible, fast, and reproducible tests to help diagnose these frequent conditions. The expanded focus on the application of artificial intelligence (AI) with respect to diagnostic cardiovascular imaging has also been applied to CXR, with several publications suggesting that AI models can be trained to detect cardiovascular conditions by identifying features in the CXR. Multiple models have been developed to predict mortality, cardiovascular morphology and function, coronary artery disease, valvular heart diseases, aortic diseases, arrhythmias, pulmonary hypertension, and heart failure. The available evidence demonstrates that the use of AI-based tools applied to CXR for the diagnosis of cardiovascular conditions and prognostication has the potential to transform clinical care. AI-analyzed CXRs could be utilized in the future as a complimentary, easy-to-apply technology to improve diagnosis and risk stratification for cardiovascular diseases. Such advances will likely help better target more advanced investigations, which may reduce the burden of testing in some cases, as well as better identify higher-risk patients who would benefit from earlier, dedicated, and comprehensive cardiovascular evaluation.
International Consensus Statement on Allergy and Rhinology: Sinonasal Tumors
Adappa, Nithin D. , Beswick, Daniel M. , London, Nyall R. , Su, Shirley Y. , Wang, Marilene B. , Alexiev, Borislav A. , Antognoni, Paolo , Alonso‐Basanta, Michelle , Batra, Pete S., Bhayani, Mihir K. , Bell, Diana , Betz, Christian , Callejas, Claudio , Casiano, Roy R. , Chatzinakis, Vasileios , Chen, Simon , Chowdhury, Naweed I. , Citardi, Martin J. , Cohen, Marc A. , Dagan, Roi , Dalfino, Gianluca , Dassi, Camila , Almeida, John R. de , Tos, Angelo Paolo Dei , DelGaudio, John M. , Ebert, Charles S. , Eloy, Jean Anderson , Evans, James J., Fang, Christina H. , Farrell, Nyssa Fox , Ferrari, Marco , Fischbein, Nancy J. , Folbe, Adam J. , Fox, Meha G. , Lund, Valerie J. , Gallia, Gary L. , Gardner, Paul A. , Getz, Anne E., Govindaraj, Satish, Gray, Stacey T. , Gross, Bradley A. , Guo, Ruifeng , Ha, Patrick K. , Halderman, Ashleigh A. , Hanna, Ehab Y., Harvey, Richard J. , Hernandez, Stephen, Hopkins, Claire , Huang, Zhigang , Huang, Zhenxiao , Humphreys, Ian M. , Hwang, Peter H. , Iloreta, Alfred Marc, Ishii, Masaru , Jafari, Aria , Kennedy, David W. , Khan, Mohemmed, Kimple, Adam J. , Kingdom, Todd T. , Knisely, Anna, Kuo, Ying‐Ju , Lamarre, Eric , Lan, Ming‐Ying , Le, Hien , Lee, Nancy Y. , Lee, Jivianne K., Lee, Victor , Levine, Corinna G. , Lin, Jin‐Ching , Lin, Derrick T., Locke, Tran B. , Luong, Amber , Magliocca, Kelly R. , Matnjani, G., Meço, Cem , Michel, Loren S. , Na'ara, Shorook, Nicolai, Piero , Nuss, Daniel W. , Nyquist, Gurston , Oakley, Gretchen M. , Omura, Kazuhiro , Orlandi, Richard R. , Otori, Nobuyoshi , Papagiannopoulos, Peter , Patel, Zara M. , Pfister, David G. , Rabinowitz, Mindy, Sanusi, Olabisi , Sargi, Zoukaa , Schafhausen, Philippe, Schlosser, Rodney J. , Sedaghat, Ahmad R. , Senior, Brent A. , Shrivastava, Raj , Sindwani, Raj , Smith, Timothy L. , Smith, Kristine A. , Solares, C. Arturo , Stamm, Aldo Cassol , Stölzel, Katharina , Sumer, Baran D. , Tajudeen, Bobby A. , Thorp, Brian D. , Tsang, Raymond K. , VanKoevering, Kyle K. , Welch, Kevin C. , Wise, Sarah K. , Witterick, Ian , Won, Tae‐Bin , Wong, Stéphanie , Woodworth, Bradford A. , Wormald, Peter‐John , Zhou, Bing , Adappa, Nithin D. , Chapurin, Nikita , Ayoub, Noel , Bitner, Benjamin F. , Chang, Michael T. , Kuan, Edward C , Wang, Eric W , Beswick, Daniel , Wang, Marilene B , Alt, Jeremiah A , Bleier, Benjamin , Callejas, Claudio , Choby, Garret , Dalfino, Gianluca , Eloy, Jean Anderson , Fang, Christina H , Farrell, Nyssa F , Ferrari, Marco , Georgalas, Christos , Grayson, Jessica W , Harvey, Richard J , Holtzman, Adam L. , Hopkins, Claire , Humphreys, Ian M , Hwang, Peter H , Jafari, Aria , Kimple, Adam J , Lal, Devyani , Lan, Ming-Ying , Luong, Amber U , Meço, Cem , Omura, Kazuhiro , Orlandi, Richard , Patel, Zara , Sedaghat, Ahmad R , Senior, Brent A , Smith, Timothy L , Smith, Kristine , Snyderman, Carl H , Tong, Charles C L , van Zele, Thibaut , Won, Tae-Bin , Woodworth, Bradford A , Yao, William C , Yeh, Chien-Fu , Zhou, Bing , Schlosser, Rodney J , Bitner, Benjamin , Guo, Ruifeng , Chang, Michael T , Su, Shirley Y , Locke, Tran Bao , Adappa, Nithin D. , Abuzeid, Waleed M. , Alt, Jeremiah A. , Bernal‐Sprekelsen, Manuel , Blay, Jean‐Yves , Bleier, Benjamin S. , Bonilla‐Velez, Juliana , Carrau, Ricardo L. , Castelnuovo, Paolo , Chandra, Rakesh Kumar , Chiu, Alexander G. , Choby, Garret , Dallan, Iacopo , El‐Sayed, Ivan H. , Fokkens, Wytske Johanna , Geltzeiler, Mathew , Grayson, Jessica W. , Gross, Bradley , Grube, Jordon G. , Hanna, Ehab Y., Ivan, Michael E , Khan, Mohemmed N., Lal, Devyani , Lechner, Matt , Lobo, Brian C. , Markovic, Svetomir N. , McKean, Erin L. , Mendenhall, William M , Phan, Jack , Psaltis, Alkis J. , Ramanathan, Murugappan , Rimmer, Ryan , Rosen, Marc R , Sreenath, Satyan B , Šurda, Pavol , Thompson, Lester D.�R. , Turner, Justin H. , Turri‐Zanoni, Mario , Udager, Aaron M , Yao, William C.

International Forum of Allergy & Rhinology | September 2, 2023 | Volume: 14 | Issue: 2 | Pages: 149-608

10.1002/alr.23262 | PMID 37658764 Get It

Abstract Background Sinonasal neoplasms, whether benign and malignant, pose a significant challenge to clinicians and represent a model area for multidisciplinary collaboration in order to optimize patient care. The International Consensus Statement on Allergy and Rhinology: Sinonasal Tumors (ICSNT) aims to summarize the best available evidence and presents 48 thematic and histopathology‐based topics spanning the field. Methods In accordance with prior International Consensus Statement on Allergy and Rhinology documents, ICSNT assigned each topic as an Evidence‐Based Review with Recommendations, Evidence‐Based Review, and Literature Review based on the level of evidence. An international group of multidisciplinary author teams were assembled for the topic reviews using the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses format, and completed sections underwent a thorough and iterative consensus‐building process. The final document underwent rigorous synthesis and review prior to publication. Results The ICSNT document consists of four major sections: general principles, benign neoplasms and lesions, malignant neoplasms, and quality of life and surveillance. It covers 48 conceptual and/or histopathology‐based topics relevant to sinonasal neoplasms and masses. Topics with a high level of evidence provided specific recommendations, while other areas summarized the current state of evidence. A final section highlights research opportunities and future directions, contributing to advancing knowledge and community intervention. Conclusion As an embodiment of the multidisciplinary and collaborative model of care in sinonasal neoplasms and masses, ICSNT was designed as a comprehensive, international, and multidisciplinary collaborative endeavor. Its primary objective is to summarize the existing evidence in the field of sinonasal neoplasms and masses.
Current Management and Future Perspectives in the Treatment of Lp(a) with a Focus on the Prevention of Cardiovascular Diseases
Farina, Juan M. , Pereyra, Milagros , Mahmoud, Ahmed , Barry, Timothy , Demeter, Susan M. Halli, Ayoub, Chadi , Arsanjani, Reza , Mahmoud, Ahmed K , Barry, Timothy , Halli Demeter, Susan M , Arsanjani, Reza , Farina, Juan M , Pereyra, Milagros , Chao, Chieh‐Ju , Demeter, Susan Halli

Pharmaceuticals | June 26, 2023 | Volume: 16 | Issue: 7 | Pages: 919

10.3390/ph16070919 | PMID 37513831 Get It

Lipoprotein(a) [Lp(a)] is a lipid molecule with atherogenic, inflammatory, thrombotic, and antifibrinolytic effects, whose concentrations are predominantly genetically determined. The association between Lp(a) and cardiovascular diseases (CVDs) has been well-established in numerous studies, and the ability to measure Lp(a) levels is widely available in the community. As such, there has been increasing interest in Lp(a) as a therapeutic target for the prevention of CVD. The impact of the currently available lipid-modifying agents on Lp(a) is modest and heterogeneous, except for the monoclonal antibody proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i), which demonstrated a significant reduction in Lp(a) levels. However, the absolute reduction in Lp(a) to significantly decrease CVD outcomes has not been definitely established, and the magnitude of the effect of PCSK9i seems insufficient to directly reduce the Lp(a)-related CVD risk. Therefore, emerging therapies are being developed that specifically aim to lower Lp(a) levels and the risk of CVD, including RNA interference (RNAi) agents, which have the capacity for temporary and reversible downregulation of gene expression. This review article aims to summarize the effects of Lp(a) on CVD and to evaluate the available evidence on established and emerging therapies targeting Lp(a) levels, focusing on the potential reduction of CVD risk attributable to Lp(a) concentrations.
Lidocaine for Neuropathic Cancer Pain (LiCPain): study protocol for a mixed-methods pilot study
Lee, Jessica , Currow, David C. , Phillips, Jane , McLachlan, Andrew J. , Ritchie, Megan, Fazekas, Belinda, Aggarwal, Rajesh , Seah, Davinia , Chye, Richard , Noble, Beverly, Aggarwal, Ghauri, George, Rachel, Kow, Marian, Ayoub, Chadi , Linton, Anthony , Sanderson, Christine , Mittal, Dipti, Rao, Angela , Prael, Grace , Urban, Katalin, Vandersman, Priyanka , Agar, Meera , McCaffrey, Nikki , Lovell, Melanie R , Brown, Linda , Sheehan, Caitlin

BMJ Open | February 21, 2023 | Volume: 13 | Issue: 2 | Pages: e066125

10.1136/bmjopen-2022-066125 | PMID 36810169 Get It

Introduction Many patients experience unrelieved neuropathic cancer-related pain. Most current analgesic therapies have psychoactive side effects, lack efficacy data for this indication and have potential medication-related harms. The local anaesthetic lidocaine (lignocaine) has the potential to help manage neuropathic cancer-related pain when administered as an extended, continuous subcutaneous infusion. Data support lidocaine as a promising, safe agent in this setting, warranting further evaluation in robust, randomised controlled trials. This protocol describes the design of a pilot study to evaluate this intervention and explains the pharmacokinetic, efficacy and adverse effects evidence informing the design. Methods and analysis A mixed-methods pilot study will determine the feasibility of an international first, definitive phase III trial to evaluate the efficacy and safety of an extended continuous subcutaneous infusion of lidocaine for neuropathic cancer-related pain. This study will comprise: a phase II double-blind randomised controlled parallel-group pilot of subcutaneous infusion of lidocaine hydrochloride 10% w/v (3000 mg/30 mL) or placebo (sodium chloride 0.9%) over 72 hours for neuropathic cancer-related pain, a pharmacokinetic substudy and a qualitative substudy of patients’ and carers’ experiences. The pilot study will provide important safety data and help inform the methodology of a definitive trial, including testing proposed recruitment strategy, randomisation, outcome measures and patients’ acceptability of the methodology, as well as providing a signal of whether this area should be further investigated. Ethics and dissemination Participant safety is paramount and standardised assessments for adverse effects are built into the trial protocol. Findings will be published in a peer-reviewed journal and presented at conferences. This study will be considered suitable to progress to a phase III study if there is a completion rate where the CI includes 80% and excludes 60%. The protocol and Patient Information and Consent Form have been approved by Sydney Local Health District (Concord) Human Research Ethics Committee 2019/ETH07984 and University of Technology Sydney ETH17-1820. Trial registration number ANZCTR ACTRN12617000747325.