scholarly journals GB0139, an inhaled small molecule inhibitor of galectin-3, in COVID-19 pneumonitis: a randomised, controlled, open-label, phase 2a experimental medicine trial of the safety, pharmacokinetics, and potential therapeutic value

2021 ◽  
Author(s):  
Erin Gaughan ◽  
Tariq Sethi ◽  
Tom Quinn ◽  
Nikhil Hirani ◽  
Andrew Mills ◽  
...  
Keyword(s):  
Adverse Events ◽  
Therapeutic Potential ◽  
Plasma Concentrations ◽  
Experimental Medicine ◽  
Target Engagement ◽  
Serious Adverse Events ◽  
Hospitalised Patients ◽  
Galectin 3 ◽  
Highest Posterior Density ◽  
Inspired Oxygen

Rationale: High galectin-3 levels predict poor outcomes in patients with COVID-19. Galectin-3 activates monocytes and macrophages which are directly implicated in COVID-19 immunopathology and the cytokine storm. GB0139 is a potent thiodigalactoside galectin-3 inhibitor and may reduce the severe effects of the disease. We report safety and pharmacokinetics and pharmacodynamics of the inhaled galectin-3 inhibitor, GB0139, and assess clinical outcomes and key systemic inflammatory biomarkers in hospitalised patients with COVID-19 (ClinicalTrials.gov/EudraCT identifier: NCT04473053/2020-002230-32). Methods: Adults with COVID-19 requiring oxygen, and with pneumonitis on x-ray, were randomised to receive standard of care (SOC; including dexamethasone; n=21) or SOC plus 10 mg GB0139 twice daily for 48 hours, then once daily for ≤14 days (n=20). Results: Patients aged 27–87 years were enrolled from July 2020; the final patient completed the 90-day follow-up in April 2021. GB0139+SOC was well tolerated with no treatment-related serious adverse events reported. Incidences of adverse events were similar between treatment arms (40 with GB0139+SOC vs 35 with SOC). Plasma GB0139 was measurable in all patients after inhaled exposure, with moderate interpatient variability, and demonstrated target engagement with decreased circulating galectin (overall treatment effect post-hoc over days 2–7: p=0·0099 vs SOC). Rate of decline in fraction of inspired oxygen (%) requirement was significantly greater in the GB0139+SOC arm with a posterior mean difference of −1 ·51 (95% highest posterior density: −2·90, −0·189) versus SOC. Plasma levels of biomarkers associated with inflammation, coagulopathy, major organ function and fibrosis showed a downward trend versus SOC. Conclusions: GB0139+SOC was well tolerated and achieved clinically relevant plasma concentrations and target engagement. This, and the reduction in markers associated with inflammatory, coagulation, fibrosis, and reduction in inspired oxygen (%) over SOC alone, indicates the therapeutic potential for inhaled GB0139 in hospitalised patients with COVID-19.

Tonabersat, a Gap-Junction Modulator: Efficacy and Safety in Two Randomized, Placebo-Controlled, Dose-Ranging Studies of Acute Migraineceph

Cephalalgia ◽  
2009 ◽  
Vol 29 (2_suppl) ◽  
pp. 17-27 ◽  
Author(s):  
SD Silberstein ◽  
J Schoenen ◽  
H Göbel ◽  
HC Diener ◽  
AH Elkind ◽  
...  
Keyword(s):  
Adverse Events ◽  
North American ◽  
Cortical Spreading Depression ◽  
Spreading Depression ◽  
Plasma Concentrations ◽  
International Study ◽  
Maximum Plasma ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Dose Ranging

Tonabersat is a novel benzopyran derivative that blocks the cortical spreading depression proposed to be associated with migraine attacks. The ability of single oral doses of 15, 25, 40 and 80 mg of tonabersat to relieve the symptoms of moderate to severe migraine was evaluated in 859 migraineurs enrolled in two dose-ranging, double-blind, randomized, placebo-controlled, parallel-group trials, one international and the other North American. In the international study, significantly more patients given tonabersat than given placebo experienced relief of headache pain at 2 h (15 mg, 36.8%; 40 mg, 40.7%), the principal efficacy variable, and at 4 h (40 mg, 63.0%) and complete abolition of headache at 4 h (40 mg, 34.3%). None of the primary or secondary efficacy variables indicated significant differences between tonabersat and placebo in the North American study. Tonabersat was generally well tolerated, with dizziness and nausea the most common side-effects. Serious adverse events were uncommon, and no patient withdrew from either study because of adverse events. These results suggest a possible interplay between tonabersat pharmacokinetics (the relatively long time required to reach maximum plasma concentrations) and patient characteristics (previous triptan exposure) in the management of acute migraine attacks. Based on the pharmacokinetics and actions on cortical spreading depression, tonabersat may have potential value in migraine prophylaxis.

Pharmacological management of treatment-resistant schizophrenia: advanced use of clozapine

2018 ◽  
Author(s):  
Siobhan Gee ◽  
David Taylor
Keyword(s):  
Older Adults ◽  
Adverse Events ◽  
Plasma Concentrations ◽  
Practical Experience ◽  
Treatment Resistant ◽  
Serious Adverse Events ◽  
Pharmacological Management ◽  
Off Label ◽  
Theoretical Support ◽  
The Uk

Clozapine is licensed in the UK for use in treatment-resistant schizophrenia, treatment-intolerant schizophrenia, or psychosis associated with Parkinson’s disease. As with many drugs, it is also used outside of these licensing parameters for other conditions or clinical situations—often referred to as ‘off-label’ prescribing. These off-label indications have varying degrees of theoretical support, peer-reviewed evidence, and practical experience associated with them. This chapter discusses the use of clozapine for children and adolescents, older adults, and in the treatment of aggression and mood disorders. The use of supramaximal doses of clozapine to achieve therapeutic plasma concentrations is also off-label, although adding interacting medication to reach the same result is not; these contrasting approaches are also debated. Finally, rechallenging with clozapine in patients who have previously had serious adverse events to the drug is also considered.

Pharmacokinetics of Tecarfarin and Warfarin in Patients with Severe Chronic Kidney Disease

2017 ◽  
Vol 117 (11) ◽  
pp. 2026-2033 ◽  
Author(s):  
Detlef Albrecht ◽  
Mintu Turakhia ◽  
Daniel Ries ◽  
Thomas Marbury ◽  
William Smith ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Adverse Events ◽  
Plasma Concentrations ◽  
Anticoagulation Therapy ◽  
Serious Adverse Events ◽  
Single Dose Study ◽  
Cyp2c9 Genotype ◽  
The Difference ◽  
Repeated Dosing

AbstractChronic kidney disease (CKD) complicates warfarin anticoagulation partially through its effect on CYP2C9 activity. Tecarfarin, a novel vitamin K antagonist, is not metabolized by CYP2C9. To evaluate the effect of CKD on their metabolism, we measured PK parameters of warfarin and tecarfarin in subjects with and without CKD. CKD subjects with estimated glomerular filtration rate < 30 mL/min not on dialysis (n = 13) were matched to healthy volunteers (HVs) (n = 10). Each subject was randomized to either warfarin 10 mg or tecarfarin 30 mg and was later crossed over to the other drug. PK parameters were measured following each drug. Mean plasma concentrations of (S)-warfarin and (R,S)-warfarin were higher (44 and 27%, respectively) in the subjects with CKD than in the healthy subjects. Both of these values fell outside of the 90% confidence interval of equivalence. For tecarfarin, the difference was less than 15% higher. Elimination half-life (t 1/2) increased by 20% for (S)-warfarin and by 8% for (R,S)-warfarin and decreased by 8% for tecarfarin. The mean plasma concentration for tecarfarin's inactive metabolite ATI-5900 increased by approximately eightfold. CKD increased the effect of CYP2C9 genetic variation on (S)-warfarin and (R,S)-warfarin metabolism. Tecarfarin exposure was similar between the HVs and the CKD subjects regardless of CYP2C9 genotype. There were neither serious adverse events (SAEs) nor treatment-emergent adverse events (TEAEs) for any subject in the study. CKD inhibits metabolism of (S)-warfarin and (R,S)-warfarin, but not tecarfarin. The safety of repeated dosing of tecarfarin in CKD patients remains unknown. However, if the PK findings of this single-dose study are present with repeated dosing, tecarfarin may lead to dosing that is more predictable than warfarin in CKD patients who require anticoagulation therapy.

scholarly journals Safety and Potential Risks with Fecal Microbiota Transplantation

2021 ◽  
Author(s):  
Pratyusha Gaonkar
Keyword(s):  
Adverse Events ◽  
Therapeutic Potential ◽  
Fecal Microbiota Transplantation ◽  
Standard Of Care ◽  
Fecal Microbiota ◽  
Serious Adverse Events ◽  
Recurrent Clostridium Difficile Infection ◽  
Long Term Follow Up

The therapeutic potential of Fecal Microbiota Transplantation (FMT) is greatly proved worldwide in the recent years. The use of FMT is now an accepted treatment modality and effective standard of care for some patients owing to its success in treating recurrent Clostridium Difficile Infection (rCDI). However, it is still evolving and longer term follow-up data regarding safety are required. Post-FMT serious adverse events (SAEs) have been varied between studies, however have included significant morbidity necessitating hospital admission and mortality in the follow-up period. The follow-up of FMT recipients should be long enough to completely establish efficacy/adverse events. Furthermore, it is recommended that FMT should be offered with caution to immunosuppressed patients, in whom FMT appears efficacious without significant additional adverse effects. In the wake of COVID-19 situation, stringent policies in screening the FMT donors have to be put forth to ensure patient safety. There is a need for high-quality, large, prospective, randomized controlled trials and long-term follow-up investigating screened donors and recipients to evaluate the long term safety and the risk–benefit profile of this promising therapy.

scholarly journals Phase Ib Trial To Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of Filociclovir (MBX-400, Cyclopropavir) in Healthy Volunteers

2019 ◽  
Vol 63 (9) ◽  
Author(s):  
Nadine G. Rouphael ◽  
Selwyn J. Hurwitz ◽  
Mari Hart ◽  
Allison Beck ◽  
Evan J. Anderson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Laboratory ◽  
Subcutaneous Tissue ◽  
Phase 1 ◽  
Plasma Concentrations ◽  
Pharmacokinetic Parameters ◽  
Plasma Exposure ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Time Curve

ABSTRACT Filociclovir (MBX-400, cyclopropavir) is an antiviral agent with activity against cytomegalovirus (CMV). A phase 1, double-blind, randomized, placebo-controlled (3:1 ratio), single-center, multiple-ascending-dose trial was conducted to assess the safety, tolerability, and pharmacokinetics of filociclovir. Filociclovir (n = 18) or placebo (n = 6) was administered as a daily oral dose (100 mg, 350 mg, or 750 mg) for 7 days to normal healthy adults (ages, 25 to 65 years) who were monitored for 22 days. Safety assessments included clinical, laboratory, and electrocardiogram monitoring. Plasma and urine samplings were used to determine pharmacokinetic parameters. All study product-related adverse events were mild, most commonly gastrointestinal (17%), nervous system (11%), and skin and subcutaneous tissue (11%) disorders. One subject had reversible grade 3 elevation in serum creatinine and bilirubin, which was associated with an ∼1-log increase in plasma filociclovir exposure compared to levels for other subjects in the same (750-mg) cohort. No other serious adverse events were observed. Plasma exposures (area under the concentration-time curve from 0 to 24 h [AUC0–24]) on days 1 and 7 were similar, suggesting negligible dose accumulation. There was a sublinear increase in plasma exposure with dose, which plateaued at the daily dose of 350 mg. The amount of filociclovir recovered in the urine remained proportional to plasma exposure (AUC). Doses as low as 100 mg achieved plasma concentrations sufficient to inhibit CMV in vitro. (This study has been registered at ClinicalTrials.gov under identifier NCT02454699.)

Stimulation of Platelet Production in Healthy Volunteers by a Novel Pegylated Peptide-Based Thrombopoietin (TPO) Receptor Agonist.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 1249-1249 ◽  
Author(s):  
Dirk Cerneus ◽  
K. Brown ◽  
R. Harris ◽  
D. End ◽  
C. Molloy ◽  
...  
Keyword(s):  
Adverse Events ◽  
Receptor Agonist ◽  
Dose Range ◽  
Plasma Concentrations ◽  
Blood Levels ◽  
Post Dose ◽  
Serious Adverse Events ◽  
Platelet Production ◽  
Platelet Counts

Abstract A novel, pegylated, peptide-based thrombopoietin receptor agonist (peg-TPOmp) was shown to possess in vitro and in vivo thrombopoietic activity. In cell-based assays, peg-TPOmp was active at picomolar concentrations. In vivo, peg-TPOmp increased platelet production dose-dependently in rats (ED50 single i.v. dose ~ 100 μg/kg), dogs and mice. A phase I study was conducted in healthy male volunteers to investigate the tolerability, PD and PK of peg-TPOmp. Forty volunteers were randomized to receive peg-TPOmp or placebo as a single i.v. bolus injection in a ratio of 6:2. The peg-TPOmp dose range explored was 0.375, 0.75, 1.5, 2.25 or 3 μg/kg. PK analysis indicated dose-related kinetics of peg-TPOmp, although at doses of 0.75 μg/kg or lower, plasma concentrations were generally below the LOQ of 6.25 ng/mL. Mean Cmax values ranged from 11 ng/mL for 0.75 μg/kg to 62 ng/mL at 3.0 μg/kg. The mean terminal half-life ranged from approx. 18 to 36 hours. Platelet counts increased dose-dependently reaching peak levels at Day 10–12, and counts returned to baseline within 3–4 weeks. Mean peak platelet levels ranged from 315 x109/L at 0.375 μg/kg to 685 x 109/L at 3 μg/kg. Mean increase of peak platelet counts from baseline ranged from 1.4-fold at 0.375 μg/kg to 3.2-fold at 3.0 μg/kg. Endogenous TPO levels dose-dependently increased, reaching peak levels at 3 days post-dose, possibly due to a reduced rate of clearance. No significant changes were observed in blood levels of IL-6, IL-11 and EPO levels. Platelet function, assessed as collagen-induced platelet aggregation in whole blood, was not different between the treatments. None of the subjects experienced serious adverse events or dose-limiting toxicities. The most frequently observed adverse events included mild headache and fatigue and occurred both after active treatment and placebo. No antibodies against peg-TPOmp were detected. Based on the safety, PK and PD data, peg-TPOmp shows promise as an agent to treat thrombocytopenic disorders.

scholarly journals Safety and Pharmacokinetics of IDX184, a Liver-Targeted Nucleotide Polymerase Inhibitor of Hepatitis C Virus, in Healthy Subjects

2010 ◽  
Vol 55 (1) ◽  
pp. 76-81 ◽  
Author(s):  
Xiao-Jian Zhou ◽  
Keith Pietropaolo ◽  
Jie Chen ◽  
Samina Khan ◽  
John Sullivan-Bólyai ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Adverse Events ◽  
Healthy Subjects ◽  
Plasma Concentrations ◽  
Area Under The Curve ◽  
Serious Adverse Events ◽  
Polymerase Inhibitor ◽  
Favorable Safety ◽  
Oral Doses

ABSTRACTIDX184 is a nucleotide prodrug designed to enhance formation in the liver of the active triphosphate of 2′-methylguanosine (2′-MeG), a potent and specific polymerase inhibitor of the hepatitis C virus (HCV). In the present study, single ascending oral doses of 5, 10, 25, 50, 75, and 100 mg IDX184 were administered sequentially to cohorts of 8 healthy subjects, randomized 6:2, active/placebo. Plasma and urine pharmacokinetic sampling was performed over a period of 120 h after dosing. Upon absorption, IDX184 rapidly disappeared from plasma, with a mean half-life (t1/2) of approximately 1 h, while plasma concentrations of 2′-MeG gradually increased. Consistent with a liver-targeting approach, plasma exposure of IDX184 and 2′-MeG was low and was also dose related: the mean maximum concentrations ranged from 1.1 to 17 ng/ml for IDX184 and 1.7 to 19 ng/ml for 2′-MeG, and the respective mean total area under the curve ranged from 1.2 to 22.7 and 17.3 to 334 ng·h/ml. Mean 2′-MeG plasma concentrations 24 h after dosing were 0.6 to 3 ng/ml for the 25- to 100-mg doses. Mean 2′-MeGt1/2values ranged from 18 to 43 h for doses of 25 mg and above. Mean cumulative urine excretion was 0.2% and 12 to 20% of administered doses for the unchanged IDX184 and 2′-MeG, respectively. IDX184 was safe and well tolerated; no serious adverse events (SAEs), dose-dependent adverse events (AEs), or dose-limiting toxicities were observed. The incidence of AEs and laboratory abnormalities was low and was similar among subjects receiving IDX184 or a placebo. All AEs were mild to moderate and resolved at the end of study. The favorable safety and pharmacokinetic profiles support further clinical evaluation of IDX184 in HCV-infected patients.

scholarly journals DOP72 Safety, tolerability and efficacy of anti-TL1A antibody PF-06480605 in treatment of ulcerative colitis: The open-label, multicentre, Phase 2a TUSCANY study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S108-S110
Author(s):  
S Danese ◽  
M Klopocka ◽  
E J Scherl ◽  
J Romatowski ◽  
J R Allegretti ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Therapeutic Potential ◽  
System Organ Class ◽  
Tolerability Profile ◽  
Open Label ◽  
Serious Adverse Events ◽  
Multicentre Phase ◽  
Mayo Score ◽  
Endoscopic Remission

Abstract Background Widespread disruption of the mucosal immune system is central to the pathogenesis of ulcerative colitis (UC). One component, tumour necrosis factor (TNF) α-like ligand 1A (TL1A), is upregulated at the site of active disease in UC. Treatment of preclinical rodent models with anti-TL1A antibodies decreases disease activity, highlighting their therapeutic potential for UC. PF-06480605 is a first-in-class fully human immunoglobulin G1 monoclonal antibody targeting TL1A. Methods The Phase 2a, open-label, multicentre, single-arm TUSCANY study (NCT02840721) evaluated the safety, tolerability and efficacy of PF-06480605 in treatment of moderate to severe UC. Participants received 500 mg intravenous (IV) PF-06480605 every 2 weeks (Q2W) for a total of 7 doses, with a 14-week follow-up period. Primary safety and efficacy endpoints were incidence of treatment-emergent adverse events (TEAEs) and endoscopic improvement (EI) (Mayo endoscopic subscore [centrally read] of ≤1 without friability) at Week 14, respectively. Secondary efficacy endpoints included remission (total Mayo score ≤2, with no individual subscore &gt;1) and endoscopic remission (Mayo endoscopic subscore = 0) at Week 14. Transcriptomic profiling on intestinal biopsies was performed. Results Of the 50 participants who received PF-06480605, 42 completed the study. The majority were male (56.0%) and white (96.0%), with a mean age of 40.0 years and prior experience of anti-TNF inhibitors (72.0%). Pancolitis (48.0%) and left-sided colitis (32.0%) were the most common forms of UC at baseline. There were 109 TEAEs, of which 18 were treatment-related. Aside from worsening UC, the most common TEAE by system organ class was arthralgia, which occurred in 6 participants, and 1 was treatment-related. Treatment-emergent serious adverse events were reported in 3 participants, and considered treatment-related in 1 participant (Table 1). No malignancies or deaths were reported. At Week 14, statistically significant EI was observed in 38.2% of participants (Table 2). The proportions of participants achieving remission and endoscopic remission at Week 14 were 24.0% and 10.0%, respectively. Transcriptomic analyses demonstrated normalisation towards a non-inflamed transcriptome in participants with EI. Conclusion PF-06480605 exhibited an acceptable safety and tolerability profile and statistically significant EI in participants with moderate to severe UC. These results warrant further evaluation in subsequent studies.

scholarly journals Evaluation of the Pharmacokinetic Drug–Drug Interaction between Micronized Fenofibrate and Pitavastatin in Healthy Volunteers

Pharmaceutics ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 869
Author(s):  
Hae Won Lee ◽  
Woo Youl Kang ◽  
Wookjae Jung ◽  
Mi-Ri Gwon ◽  
Kyunghee Cho ◽  
...  
Keyword(s):  
Adverse Events ◽  
Healthy Volunteers ◽  
Combined Treatment ◽  
Plasma Concentrations ◽  
Lipid Lowering ◽  
Fenofibric Acid ◽  
Serious Adverse Events ◽  
Once Daily ◽  
Pharmacokinetic Interactions ◽  
Micronized Fenofibrate

Dyslipidemia is a major risk factor for development of atherosclerosis and cardiovascular disease (CVD). Effective lipid-lowering therapies has led to CVD risk reduction. This study evaluated the possible pharmacokinetic interactions between fenofibrate, a peroxisome proliferators-activated receptors α agonist, and pitavastatin, a 3-hydoxy-3-methylglutaryl-coenzyme A reductase inhibitor, in healthy Korean subjects. The study design was an open-label, randomized, multiple-dose, three-period, and six-sequence crossover study with a 10-day washout in 24 healthy volunteers. It had three treatments: 160 mg of micronized fenofibrate once daily for 5 days; 2 mg of pitavastatin once daily for 5 days; and 160 mg of micronized fenofibrate with 2 mg of pitavastatin for 5 days. Serial blood samples were collected at scheduled intervals for up to 48 h after the last dose in each period to determine the steady-state pharmacokinetics of both drugs. Plasma concentrations of fenofibric acid and pitavastatin were measured using a validated high-performance liquid chromatography with the tandem mass spectrometry method. A total of 24 subjects completed the study. Pitavastatin, when co-administered with micronized fenofibrate, had no effect on the Cmax,ss and AUCτ,ss of fenofibric acid. The Cmax,ss and AUCτ,ss of pitavastatin were increased by 36% and 12%, respectively, when co-administered with fenofibrate. Combined treatment with pitavastatin and micronized fenofibrate was generally well tolerated without serious adverse events. Our results demonstrated no clinically significant pharmacokinetic interactions between micronized fenofibrate and pitavastatin when 160 mg of micronized fenofibrate and 2 mg of pitavastatin are co-administered. The treatments were well tolerated during the study, with no serious adverse events.

scholarly journals SAFety, Effectiveness of care and Resource use among Australian Hospitals (SAFER Hospitals): a protocol for a population-wide cohort study of outcomes of hospital care

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e035446
Author(s):  
Isuru Ranasinghe ◽  
Sadia Hossain ◽  
Anna Ali ◽  
Dennis Horton ◽  
Robert JT Adams ◽  
...  
Keyword(s):  
Cohort Study ◽  
Adverse Events ◽  
Emergency Care ◽  
Resource Use ◽  
Hospital Costs ◽  
Adverse Outcomes ◽  
Serious Adverse Events ◽  
Hospitalised Patients ◽  
Effectiveness Of Care ◽  
Safety Effectiveness

IntroductionDespite global concerns about the safety and quality of health care, population-wide studies of hospital outcomes are uncommon. The SAFety, Effectiveness of care and Resource use among Australian Hospitals (SAFER Hospitals) study seeks to estimate the incidence of serious adverse events, mortality, unplanned rehospitalisations and direct costs following hospital encounters using nationwide data, and to assess the variation and trends in these outcomes.Methods and analysisSAFER Hospitals is a cohort study with retrospective and prospective components. The retrospective component uses data from 2012 to 2018 on all hospitalised patients age ≥18 years included in each State and Territories’ Admitted Patient Collections. These routinely collected datasets record every hospital encounter from all public and most private hospitals using a standardised set of variables including patient demographics, primary and secondary diagnoses, procedures and patient status at discharge. The study outcomes are deaths, adverse events, readmissions and emergency care visits. Hospitalisation data will be linked to subsequent hospitalisations and each region’s Emergency Department Data Collections and Death Registries to assess readmissions, emergency care encounters and deaths after discharge. Direct hospital costs associated with adverse outcomes will be estimated using data from the National Cost Data Collection. Variation in these outcomes among hospitals will be assessed adjusting for differences in hospitals’ case-mix. The prospective component of the study will evaluate the temporal change in outcomes every 4 years from 2019 until 2030.Ethics and disseminationHuman Research Ethics Committees of the respective Australian states and territories provided ethical approval to conduct this study. A waiver of informed consent was granted for the use of de-identified patient data. Study findings will be disseminated via presentations at conferences and publications in peer-reviewed journals.

Sign in / Sign up

Export Citation Format

Share Document