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Concentration-QT modeling shows no evidence of clinically significant QT interval prolongation with capivasertib at expected therapeutic concentrations.

Br J Clin Pharmacol 2021 Jul 26. Epub 2021 Jul 26.

Clinical Pharmacology and Quantitative Pharmacology, BioPharmaceuticals R&D, AstraZeneca R&D, Cambridge, UK.

Pharmacokinetics-matched digital electrocardiogram data (n = 503 measurements from 180 patients) collected in a first-in-human, multi-part, dose-escalation (from 80 to 800 mg) and dose expansion (at 480 mg) phase 1 study in patients with advanced solid malignancies, were used to assess potential risk of QT prolongation associated with the AKT inhibitor capivasertib. The relationship between plasma drug concentrations and baseline-adjusted Fridericia-corrected QT (ΔQTcF) values was estimated using a prespecified linear mixed-effects model. The model provided an unbiased reproduction of the experimental data set, estimating a small but positive correlation between capivasertib concentration and ΔQTcF. Read More

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Validated Simultaneous Gradient Ultra-Performance Liquid Chromatographic Quantification of Some Proton Pump Inhibitor Drug Residues in Saudi Pharmaceutical Industrial Wastewater.

Molecules 2021 Jul 19;26(14). Epub 2021 Jul 19.

Pharmaceutical Chemistry Department, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al Kharj 11942, Saudi Arabia.

Monitoring and quantification of active pharmaceutical ingredients (APIs) in the environment constitute important and challenging tasks, as they are directly associated with human health. Three commonly used proton pump inhibitors (PPIs), namely, omeprazole sodium (OMP), pantoprazole sodium (PNT), and lansoprazole sodium (LNZ) are well separated and quantified using ultra-performance liquid chromatography (UPLC) in pharmaceutical industrial wastewater. The separation of the studied drugs was performed on a stationary phase with a Waters column (100 × 2. Read More

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Development, Validation and Application of an ICP-SFMS Method for the Determination of Metals in Protein Powder Samples, Sourced in Ireland, with Risk Assessment for Irish Consumers.

Molecules 2021 Jul 18;26(14). Epub 2021 Jul 18.

Mass Spectrometry Group (MSG), Department of Physical Sciences, Munster Technological University (MTU), Rossa Avenue, Bishopstown, T12 P928 Cork, Ireland.

A method has been developed, optimised and validated to analyse protein powder supplements on an inductively coupled plasma-sector field mass spectrometer (ICP-SFMS), with reference to ICH Guideline Q2 Validation of Analytical Procedures: Text and Methodology. This method was used in the assessment of twenty-one ( = 21) elements (Al, Au, Ba, Be, Bi, Cd, Co, Cr, Cu, Fe, Hg, Li, Mg, Mn, Mo, Pb, Pt, Sn, Ti, Tl, V) to evaluate the safety of thirty-six ( = 36) protein powder samples that were commercially available in the Irish marketplace in 2016/2017. Using the determined concentrations of elements in samples (µg·kg), a human health risk assessment was carried out to evaluate the potential carcinogenic and other risks to consumers of these products. Read More

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Application of intraoperative ultrasound in neurosurgery for hypertensive intracerebral hemorrhage.

J Clin Neurosci 2021 Aug 15;90:251-255. Epub 2021 Jun 15.

Department of Neurosurgery, Affiliated Hospital of Nantong University, Nantong, Jiangsu Province, China. Electronic address:

Objective: To explore the clinical significance of intraoperative ultrasound in neurosurgery for hypertensive intracerebral hemorrhage (ICH).

Methods: Patients with hypertensive ICH who required to undergo surgical treatment were assigned into treatment group (126 cases), who were assisted by intraoperative ultrasound, and control group (122 cases), who were not assisted by intraoperative ultrasound. In the treatment group, intraoperative ultrasound was used for real-time positioning after opening the bone flap, so as to guide the surgery. Read More

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Antiplatelet therapy and future intracerebral hemorrhage in hemodialysis patients with cerebral microbleeds.

J Clin Neurosci 2021 Aug 8;90:155-160. Epub 2021 Jun 8.

Department of Medical Statistics, Osaka City University, Osaka, Osaka, Japan.

The use of antiplatelet drugs is thought to increase the risk for intracerebral hemorrhage (ICH) in patients with cerebral microbleeds (CMBs). However, hemodialysis (HD) patients have a high prevalence of CMBs and diverse pathologies that require antiplatelet therapy. In this study, we investigated whether the use of antiplatelet drugs increases the risk for ICH in HD patients with CMBs. Read More

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Characteristics and predictors of early hospital deaths in newly diagnosed APL: a 13-year population-wide study.

Blood Adv 2021 07;5(14):2829-2838

Department of Medicine, The University of Hong Kong, Hong Kong SAR, China.

Despite therapeutic advances, early death (ED) remains a major factor curtailing survival of acute promyelocytic leukemia (APL). Studies examining factors that cause early death (ED; within 30 days of admission) and the correlation of survival with the timing of administration of all-trans retinoic acid (ATRA) and hemostatic parameters are scarce. We performed a cohort analysis of nonselect patients with newly diagnosed APL who presented to the health care system in Hong Kong, where oral arsenic trioxide was used. Read More

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is a Prognostic Biomarker in Gastric Cancer and is Correlated with M2 Macrophage Infiltration.

Onco Targets Ther 2021 6;14:4099-4117. Epub 2021 Jul 6.

Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, Jiangsu, 210029, People's Republic of China.

Purpose: Follistatin-related gene 3 (), an established oncogene, can modulate target gene expression via members of the transforming growth factor β (TGF-β) superfamily. The present study was conducted to evaluate the expression of in gastric cancer (GC) and to determine its prognostic significance. We also evaluated the possible mechanisms involved in the oncogenic role of in gastric carcinogenesis and development. Read More

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Single-molecule, full-length transcript isoform sequencing reveals disease-associated RNA isoforms in cardiomyocytes.

Nat Commun 2021 07 9;12(1):4203. Epub 2021 Jul 9.

Department of Genetics, School of Medicine, Stanford University, Stanford, USA.

Alternative splicing generates differing RNA isoforms that govern phenotypic complexity of eukaryotes. Its malfunction underlies many diseases, including cancer and cardiovascular diseases. Comparative analysis of RNA isoforms at the genome-wide scale has been difficult. Read More

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Interlaboratory method validation of capillary electrophoresis sodium dodecyl sulfate (CE-SDS) methodology for analysis of mAbs.

Electrophoresis 2021 Jul 8. Epub 2021 Jul 8.

Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, No. 31, Huatuo Road, Daxing District, Beijing, 102629, P. R. China.

Capillary electrophoresis sodium dodecyl sulfate (CE-SDS) is an analytical method to assess the purity of proteins, commonly applied to monoclonal antibodies (mAbs) in the biopharmaceutical industry. To address the need to standardize the CE-SDS method in the pharmaceutical industry and to enhance the confidence in method transfer between laboratories operating different commercial capillary electrophoresis (CE) instrument platforms, an interlaboratory CE-SDS method validation was organized involving 13 laboratories in 13 companies on four different types of commercial capillary electrophoresis instrument. In the validation, a commercial mAb therapeutic was used as the sample. Read More

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Label-free photoacoustic microscopy: a potential tool for the live imaging of blood disorders in zebrafish.

Biomed Opt Express 2021 Jun 26;12(6):3643-3657. Epub 2021 May 26.

University of Michigan-Shanghai Jiao Tong University Joint Institute, Shanghai Jiao Tong University, Shanghai 200240, China.

The zebrafish has emerged as a useful model for human hematological disorders. Transgenic zebrafish that express green fluorescence protein (GFP) in red blood cells (RBCs) visualized by fluorescence microscopy (FLM) is a fundamental approach in such studies to understand the cellular processes and biological functions. However, additional and cumbersome efforts are required to breed a transgenic zebrafish line with reliable GFP expression. Read More

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Behavioral Assessment of Sensory, Motor, Emotion, and Cognition in Rodent Models of Intracerebral Hemorrhage.

Front Neurol 2021 17;12:667511. Epub 2021 Jun 17.

Department of Human Anatomy, College of Basic Medical Sciences, Zhengzhou University, Zhengzhou, China.

Intracerebral hemorrhage (ICH) is the second most common type of stroke and has one of the highest fatality rates of any disease. There are many clinical signs and symptoms after ICH due to brain cell injury and network disruption resulted from the rupture of a tiny artery and activation of inflammatory cells, such as motor dysfunction, sensory impairment, cognitive impairment, and emotional disturbance, etc. Thus, researchers have established many tests to evaluate behavioral changes in rodent ICH models, in order to achieve a better understanding and thus improvements in the prognosis for the clinical treatment of stroke. Read More

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Application of Quality by Design to the robust preparation of a liposomal GLA formulation by DELOS-susp method.

J Supercrit Fluids 2021 Jul;173:105204

Nanomol Technologies S.L., 08193 Cerdanyola del Vallès, Spain.

Fabry disease is a lysosomal storage disease arising from a deficiency of the enzyme α-galactosidase A (GLA). The enzyme deficiency results in an accumulation of glycolipids, which over time, leads to cardiovascular, cerebrovascular, and renal disease, ultimately leading to death in the fourth or fifth decade of life. Currently, lysosomal storage disorders are treated by enzyme replacement therapy (ERT) through the direct administration of the missing enzyme to the patients. Read More

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Optimization and Validation of a Facile RP-HPLC Method for Determination of Betrixaban and Lercanidipine in Pharmaceutical and Biological Matrices.

J Chromatogr Sci 2021 Jul 2. Epub 2021 Jul 2.

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, 35516, Mansoura, Egypt.

A simple, accurate, rapid and sensitive reversed-phase high-performance liquid chromatography (RP-HPLC) method was established for determination of a novel non-vitamin K antagonist oral anticoagulant drug, betrixaban, and its co-administered calcium-channel blocker drug, lercanidipine, in pharmaceutical formulations and biological fluids. The proposed HPLC method was the first chromatographic method applied to estimate this mixture in a short chromatographic run (<6 min), high resolution between betrixaban/lercanidipine (Rs = 7.12) and acceptable values of limit of detection (LOD), limit of quantification (LOQ) and percentage of relative standard deviation (%RSD). Read More

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Somatic mosaicism in the MAPK pathway in sporadic brain arteriovenous malformation and association with phenotype.

J Neurosurg 2021 Jul 2:1-8. Epub 2021 Jul 2.

Departments of1Anesthesia and Perioperative Care.

Objective: Sporadic brain arteriovenous malformation (BAVM) is a tangled vascular lesion characterized by direct artery-to-vein connections that can cause life-threatening intracerebral hemorrhage (ICH). Recently, somatic mutations in KRAS have been reported in sporadic BAVM, and mutations in other mitogen-activated protein kinase (MAPK) signaling pathway genes have been identified in other vascular malformations. The objectives of this study were to systematically evaluate somatic mutations in MAPK pathway genes in patients with sporadic BAVM lesions and to evaluate the association of somatic mutations with phenotypes of sporadic BAVM severity. Read More

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Automated Detection and Screening of Traumatic Brain Injury (TBI) Using Computed Tomography Images: A Comprehensive Review and Future Perspectives.

Int J Environ Res Public Health 2021 06 16;18(12). Epub 2021 Jun 16.

School of Engineering, Ngee Ann Polytechnic, 535 Clementi Road, Singapore 599489, Singapore.

Traumatic brain injury (TBI) occurs due to the disruption in the normal functioning of the brain by sudden external forces. The primary and secondary injuries due to TBI include intracranial hematoma (ICH), raised intracranial pressure (ICP), and midline shift (MLS), which can result in significant lifetime disabilities and death. Hence, early diagnosis of TBI is crucial to improve patient outcome. Read More

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Stability of Metronidazole and Its Complexes with Silver(I) Salts under Various Stress Conditions.

Molecules 2021 Jun 11;26(12). Epub 2021 Jun 11.

Department of Bioinorganic Chemistry, Chair of Medicinal Chemistry, Faculty of Pharmacy, Medical University of Lodz, Muszyńskiego 1, 90-151 Łódź, Poland.

Metronidazole is a drug widely used in the prevention and treatment of bacterial infections. Due to its possibility of the formation of stable metal complexes, it was decided to broaden its activity spectrum by introducing the silver(I) coordination compounds i.e. Read More

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White Matter Survival within and around the Hematoma: Quantification by MRI in Patients with Intracerebral Hemorrhage.

Biomolecules 2021 Jun 18;11(6). Epub 2021 Jun 18.

Department of Neurosurgery, University of Michigan, Ann Arbor, MI 48109, USA.

White matter (WM) injury and survival after intracerebral hemorrhage (ICH) has received insufficient attention. WM disruption surrounding the hematoma has been documented in animal models with histology, but rarely in human ICH with noninvasive means, like magnetic resonance imaging (MRI). A few human MRI studies have investigated changes in long WM tracts after ICH remote from the hematoma, like the corticospinal tract, but have not attempted to obtain an unbiased quantification of WM changes within and around the hematoma over time. Read More

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Risk Factors for the Recurrence of CVD Incidents in Post-Stroke Patients over a 5-Year Follow-Up Period Based on the ICF Classification.

Int J Environ Res Public Health 2021 06 3;18(11). Epub 2021 Jun 3.

Department of Rehabilitation and Physiotherapy, University of Medical Sciences, 28 Czerwca 1956 Str., No. 135/147, 60-545 Poznań, Poland.

Stroke is a strong risk factor for recurrent cardiovascular disease (CVD) incidents. The risk of post-stroke CVD incidents can be reduced by eliminating the most relevant risk factors. The aim of the study was to compare the incidence of recurrent CVD events and to determine the quantitative and qualitative differences in CVD risk factors over the 5-year follow-up period in patients with ischemic stroke (IS) and haemorrhagic stroke (ICH) with the use of ICF classification categories to present these differences. Read More

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Neutrophil-to-Lymphocyte Ratio as an Independent Predictor of In-Hospital Mortality in Patients with Acute Intracerebral Hemorrhage.

Medicina (Kaunas) 2021 Jun 15;57(6). Epub 2021 Jun 15.

"Carol Davila" University of Medicine and Pharmacy Bucharest, 020021 Bucharest, Romania.

: Neutrophil-to-lymphocyte ratio (NLR), a very low cost, widely available marker of systemic inflammation, has been proposed as a potential predictor of short-term outcome in patients with intracerebral hemorrhage (ICH). : Patients with ICH admitted to the Neurology Department during a two-year period were screened for inclusion. Based on eligibility criteria, 201 patients were included in the present analysis. Read More

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Targeted Metabolomics: The LC-MS/MS Based Quantification of the Metabolites Involved in the Methylation Biochemical Pathways.

Metabolites 2021 Jun 24;11(7). Epub 2021 Jun 24.

The Goulandris Natural History Museum, Bioanalytical Laboratory, GAIA Research Center, 13 Levidou Street, 14562 Kifissia, Greece.

Biochemical methylation reactions mediate the transfer of the methyl group regulating vital biochemical reactions implicated in various diseases as well as the methylation of DNA regulating the replication processes occurring in living organisms. As a finite number of methyl carriers are involved in the methyl transfer, their quantification could aid towards the assessment of an organism's methylation potential. An Hydrophilic Interaction Chromatography-Liquid Chromatography Multiple Reaction Monitoring (HILIC-LC-MRM) mass spectrometry (MS) methodology was developed and validated according to Food & Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for the simultaneous determination of nine metabolites i. Read More

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Severe thrombocytopenia is sufficient for fetal and neonatal intra-cerebral hemorrhage to occur.

Blood 2021 Jun 29. Epub 2021 Jun 29.

University of Melbourne, Australia.

Intra-cerebral hemorrhage (ICH) has a devastating impact on the neonatal population. Whether thrombocytopenia is sufficient to cause ICH in neonates is debated. In this study we have comprehensively investigated the consequences of severe thrombocytopenia on the integrity of the cerebral vasculature using two orthogonal approaches: genetically, by studying embryogenesis in the Nfe2-/- mouse line; and using biologics (anti-GP1Ba antibodies) to induce severe thrombocytopenia at defined times during development. Read More

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Proof-of-concept single-arm trial of bevacizumab therapy for brain arteriovenous malformation.

BMJ Neurol Open 2021 17;3(1):e000114. Epub 2021 Mar 17.

Radiology and Biomedical Imaging, UCSF, San Francisco, California, USA.

Brain arteriovenous malformations (bAVMs) are relatively rare, although their potential for secondary intracranial haemorrhage (ICH) makes their diagnosis and management essential to the community. Currently, invasive therapies (surgical resection, stereotactic radiosurgery and endovascular embolisation) are the only interventions that offer a reduction in ICH risk. There is no designated medical therapy for bAVM, although there is growing animal and human evidence supporting a role for bevacizumab to reduce the size of AVMs. Read More

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Encapsulated Intracerebral Hematoma Presenting as Cerebral Abscess.

Cureus 2021 May 23;13(5):e15198. Epub 2021 May 23.

Neurosurgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, USA.

Chronic encapsulated intracerebral hematoma is a rare pathology which may present after spontaneous intracerebral hemorrhage (ICH) or radiosurgery for arteriovenous malformations. A 66-year-old male presented with recent diagnosis of cerebrovascular accident (CVA) status post-treatment with tissue plasminogen activator and mechanical thrombectomy. His recent diagnoses included infective endocarditis, septic bacteremia, meningitis, and aspiration pneumonia. Read More

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Evaluation of moxifloxacin in canine and non-human primate telemetry assays: Comparison of QTc interval prolongation by timepoint and concentration-QTc analysis.

Clin Transl Sci 2021 Jun 25. Epub 2021 Jun 25.

Amgen Research, Thousand Oaks, California, USA.

The in vivo correct QT (QTc) assay is used by the pharmaceutical industry to characterize the potential for delayed ventricular repolarization and is a core safety assay mentioned in International Conference on Harmonization (ICH) S7B guideline. The typical telemetry study involves a dose-response analysis of QTc intervals over time using a crossover (CO) design. This method has proven utility but does not include direct integration of pharmacokinetic (PK) data. Read More

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Hypodensities within Hematoma is Time-Dependent and Predicts Outcome after Spontaneous Intracerebral Hemorrhage.

Neurol India 2021 May-Jun;69(3):676-680

Comprehensive Stroke Care Program, Department of Neurology, Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, India.

Background: Non-contrast CT (NCCT) brain imaging biomarkers of hematoma expansion in intracerebral hemorrhage (ICH) has gained relevance in recent times. Though intra-hematoma hypodensities (IHH) can predict hematoma expansion and outcome, it is postulated to be time-dependent.

Aim: To assess the differential prevalence of IHH in spontaneous ICH over time and assess its predictive valve in early hematoma expansion and functional outcome at 3 months. Read More

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Association between tirofiban monotherapy and efficacy and safety in acute ischemic stroke.

BMC Neurol 2021 Jun 24;21(1):237. Epub 2021 Jun 24.

Stroke Center & Department of Neurology, Division of Life Sciences and Medicine, the First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, Anhui, China.

Background: Studies have suggested that glycoprotein IIb/IIIa antagonists such as tirofiban are beneficial for patients with acute coronary syndromes. However, it is still uncertain about the efficacy and safety of tirofiban in patients with acute ischemic stroke (AIS).

Methods: In this prospective non-randomized study, 255 AIS patients were recruited from 4 comprehensive stroke centers in China between January, 2017 and May, 2018. Read More

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Early Cerebrovascular Ultrasonography as a Predictor of Hemorrhagic Transformation After Thrombectomy.

J Stroke Cerebrovasc Dis 2021 Aug 19;30(8):105922. Epub 2021 Jun 19.

Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal; Faculdade de Medicina da Universidade de Coimbra, Coimbra, Portugal.

Objectives: To determine the predictive value of early transcranial color-coded sonography (TCCS) for intracranial hemorrhage (ICH) in patients with large artery occlusion (LAO) stroke of carotid circulation, who were submitted to endovascular therapy (EVT) with successful reperfusion.

Materials And Methods: Retrospective study evaluating a cohort of consecutive stroke patients with LAO of the carotid circulation that were recanalyzed with EVT. We measured angle-corrected peak systolic velocities, end-diastolic velocities and mean flow velocities (PSV, EDV and MFV) of the symptomatic and asymptomatic middle cerebral artery (MCA). Read More

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Head Computed Tomography Scans in Elderly Patients with Low Velocity Head trauma after a Fall.

Isr Med Assoc J 2021 Jun;23(6):359-363

Department of Clinical Utility, Laniado Hospital, Netanya, Israel.

Background: Recommendations for a head computed tomography (CT) scan in elderly patients without a loss of consciousness after a traumatic brain injury and without neurological findings on admission and who are not taking oral anticoagulant therapy, are discordant.

Objectives: To determine variables associated with intracranial hemorrhage (ICH) and the need for neurosurgery in elderly patients after low velocity head trauma.

Methods: In a regional hospital, we retrospectively selected 206 consecutive patients aged ≥ 65 years with head CT scans ordered in the emergency department because of low velocity head trauma. Read More

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[Ensure care for HIV patients even during the pandemic].

MMW Fortschr Med 2021 06;163(Suppl 2):42-45

FA für Innere Medizin, Infektionsmedizinisches Centrum Hamburg, Glockengiesserwall 1, 20095, Hamburg, Germany.

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[What to do in the case of treatment failure].

MMW Fortschr Med 2021 06;163(Suppl 2):24-27

ICH Hamburg, Grindelallee 35, 20146, Hamburg, Germany.

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