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- W3159976957 abstract "Mark Yazer & Darrell Triulzi Vitalant in Pittsburgh administers a centralized transfusion service that provides transfusion medicine expertise and blood products to about 24 area hospitals. Between these hospitals, virtually all medical and surgical services are provided from neonatal to geriatric care, including several Level 1 trauma hospitals. Vitalant Pittsburgh is also the regional blood collector, collecting approximately 87 000 RBCs, 25 000 platelets, and 31 000 plasma units per year. CCP is collected at Vitalant by apheresis. Our collection of CCP is the same as for routine plasma apheresis donations in that, according to the US FDA, plasma can be donated every 28 days, up to 13 times per year. While the FDA allows donors to give plasma more frequently, as soon as 48 h apart, these are considered frequent plasma donors and require close monitoring. The FDA waived the frequent donor requirements temporarily during the pandemic. The Vitalant blood donor medical director can give medical approval for donation more frequently than 28 days on a donor-by-donor basis. CCP is collected for transfusion to patients with dyspnoea and a positive COVID-19 diagnosis. Initially, we provided CCP for use in both compassionate and study protocols, in particular the Mayo Clinic study. However, since the Mayo Clinic IND was completed, all of the CCP is provided as an investigational new drug and the physician who orders it is required to explain the investigational nature of the product to the patient and document the patient’s understanding of this fact in the consent note. Yes, a donor must have a positive test indicating that they were infected with COVID-19. We accept the results of either the PCR or the antibody test as proof that they were infected. The donor must wait 28 days after resolution of their last sign or symptom before they can donate CCP. No. As a service to the community, and as a means of identifying potential CCP donors, Vitalant tests all donors who donate whole blood or apheresis products for these antibodies. This testing is performed after the donation is made and the donor can check their results on the website. Similarly, potential donors who are referred to the blood centre by the hospital to donate CCP once they have recovered from their infection are also tested for antibodies after the donation is made. Thus, having a high titre antibody is not an exclusion criteria as the titre is determined after the donation is made. Vitalant uses the Euroimmun IgG/IgA immunoassay, with the donor plasma diluted 1:100. Yes, samples are frozen for future assessment. No, our CCP does not undergo pathogen inactivation. No. Yes, individuals who have recovered from COVID-19 can donate standard blood products 28 days after resolution of their last sign or symptom. No. Levent Tufan Kumaş For hospital For blood establishments and blood services We perform plasmapheresis for collection of CCP. Donation frequency permitted for routine plasma donation by apheresis: 48 h (Max. twice a week, totally 33 donations/year). Donation frequency permitted for CCP donation by apheresis: 10 days (Max. 8 donations in a 3 months period). CCP is collected for transfusion, and for compassionate use. Yes. Diagnosis of COVID-19 infection by a laboratory test result (Either PCR test positivity studied from the nasopharynx swab sample or serologically test positivity for SARS-CoV-2 antibodies) is considered acceptable. In addition to general blood donor selection criteria: 28 days after complete cessation of COVID-19 symptoms donors considered to be acceptable for CCP donation Or, 14 days after complete cessation of COVID-19 symptoms with 2 negative PCR test results (One of the tests must have been done within the last 48 h). No. Yes. SARS-CoV-2 IgG assay (Abbott Architect). Chemiluminescent microparticle immunoassay. Predefined index value threshold of 1·4 signal-to-cut-off (S/C) ratio for seropositivity. (Tests are run just before each donation process). No. The samples are collected from the CCP unit and freezed/archived for future assessment. No. No. Yes. The minimum deferral period after recovery before whole blood or apheresis donation is 28 days. No. According to our regulations; these people are considered to be people who have received a blood transfusion, so they cannot donate blood or plasma at least 12 months. Levent Sağdur No No Yes. ELISA (17 Regional Blood Center) and CLIA (1 regional blood center) (Euroimmun/Roche) If yes/no, are samples collected from the CCP unit and freezed/archived for future assessment? YES Yes. Mirasol® Pathogen Reduction Technology - Terumo BCT No. These people are considered to be people who have received a blood transfusion, so they cannot donate blood or plasma Yes. 28 days. No. These people are considered to be people who have received a blood transfusion, so they cannot donate blood or plasma. Nil Banu Pelit Immune plasma donation can be done within a minimum of 28 days and a maximum of 3 (three) months after recovery. The date of the first donation is accepted as the starting date and it can be made eight times in 3 months with a minimum of 10 days intervals and a maximum of three times in a month. Both. The diagnosis of COVID-19 infection was made according to the results of the laboratory test (PCR test positivity from the nasopharynx swab sample or the test positivity of SARS-CoV-2 antibodies serologically) AND. At least 28 days have passed since clinical recovery (cough, fever, shortness of breath, weakness, etc.) AND. At least 2 PCR test results from nasopharyngeal swab samples must be negative (one of the tests must have been done just before donation) AND. The result of Anti-SARS-Cov-2 antibodies is IgG Positive but IgM Negative. If there is no symptoms (weakness, cough, shortness of breath, etc.), he/she is accepted for donation. Yes, patients with negative nasopharyngeal swab test were accepted as a suitable donor. Yes, the donors are screened with rapid card tests for anti-SARS-CoV-2 IgG and IgM in donor serum/plasma. The donors who are IgG positive and IgM negative were accepted as donors. No. Yes. Yes: Cerus Corporation, Intercept Blood System. No. According to our regulations, these people are considered to be people who have received a blood transfusion, so they cannot donate blood or plasma at least 12 months. Yes, at least 28 days have passed since clinical recovery (cough, fever, shortness of breath, weakness, etc.) No. According to our regulations, these people are considered to be people who have received a blood transfusion, so they cannot donate blood or plasma at least 12 months. We had developed a project for CCP collection soon after first case in Turkey was defined. In addition to the described criteria, we also prepared cryopoor plasma and pooled plasma from them in order to decrease the coagulation factors and the effect of antibody-dependent enhancement of infection. We screened the isohemagglutinin titres before pooling. We pooled 8 units in order to have the titres below 1:32. We divided this pooled plasma into 200 ml bags. By this way, we made a composition that can be used by each patient without blood group match. We will soon publish the results of this project. At the beginning of the pandemic the CCP was used in ICU patients who had pneumonia according the MoH guidelines, however the guideline was reviewed and CCP was advised during the first 7–10 days of the infection. We think that immune plasma is more useful at initial days in order to prevent the development of pneumonia or in patients in risk groups such as medical staff and close contacts to infected people. Renée Bazin Salwa I. Hindawi & Maha A. Badawi Type of CCP donations in our institution is performed through plasmapheresis and donor can donate once or twice one week apart. Collected CCP is intended for transfusion of COVID-19 patients only under clinical trial and only few have been used as compassionate use. The CCP donor eligibility criteria used in our institution are as follow: Donor should match routine donor eligibility criteria; donors should have history of SARS-CoV-2 infection with positive confirmation for SARS-CoV-2 by PCR testing and complete recovery from symptoms of at least 2 weeks before donation. There is no need to have a confirmatory test result status of past COVID-19 infection before CCP donation but anti-SARS-CoV-2 neutralizing antibodies titre regularly done for all donors at time of donation. No need to test the CCP donor for SARS-CoV-2 by PCR before donation as he should have complete clinical recovery for 2 weeks before CCP donation. To date, we are testing all donors for SARS-CoV-2 neutralizing antibodies titre before donation through in-house neutralization test using live virus. No other antibody testing is done. We are testing only donors at time of CCP donation for SARS-CoV-2 neutralizing antibody titre testing. At our institution, CCP subjected to a pathogen reduction treatment and we use Intercept system (Amotosalen and UV light treatment). At the current time, the protocol does not clearly exclude recipients of CCP from CCP donation. However, we did not have come across any recipients of CCP whom like to donate. At our institution recipients of blood or blood components are deferred from donating any blood components for 3 months (new policy). Individuals recovered from COVID-19 infection can donate if 28 days have passed since resolution of symptoms, or 28 days after the date of the positive swab if they were asymptomatic. Recipients of blood or blood components (including recipient of CCP) are deferred from donating any blood components for 3 months. This change from the previous policy of deferral for 12 months was based on FDA guidance https://www.fda.gov/media/92490/download We faced few challenges as convincing recovered patients to donate CCP after their discharged from the hospital, as they seem to be worried about their health and contracting infection again. The other challenges are the transfusion protocol, dosing and frequency of treatment. An important lesson we learned that the recruitment of CCP donors should be started shortly after diagnosis by healthcare professionals in contact with the patient at that early stage and before discharge from the hospital. Awareness and education to the patients and society on the importance of CCP donation and its implication through distribution of educational materials and discussion with patients, through donor campaigns and social media are essential. We should be prepared with effective plan for future pandemics if any. Gopal K Patidar, Hem Chandra Pandey & Rahul Chaurasia We are a hospital-based blood transfusion service within All India Institute of Medical Sciences (AIIMS), New Delhi, India, that is one of the largest tertiary care academic hospital in North India. Our hospital has more than 2000 in-patient’s hospital beds, catering to patients of all age groups i.e. neonates, paediatrics, adults and geriatrics, across all medical and surgical specialties. We received approximately 1 50 000 blood component transfusion requests form annually from various departments out of them around 75 000 red blood cell units issued annually for transfusion. At our institution, there are three blood centres under the purview of Department of Transfusion Medicine, which collects more than 80 000 of whole blood units annually and fully process it into blood components like red blood cells, platelet concentrates and plasma. We also perform pre-transfusion testing and issue the blood components within our hospital and outsource excess plasma for fractionation. We also have apheresis facilities which mainly focuses on platelet (apheresis) collection and peripheral blood stem collection accounting for collection of 2000 apheresis units. Therapeutic procedures such as plasma exchanges are also quite frequent (400–500 plasma exchanges are performed annually). Apheresis plasma collection was not performed routinely in the pre-COVID-19 period. At our institution CCP donation is done by plasmapheresis, as per the regulations mandated under the Drugs and Cosmetic Act (second amendment) 2020, India [1]. The act recommends “The quantity of plasma separated from the blood of donor shall not exceed 500 ml per sitting and once in a fortnight or shall not exceed 1000 ml per month”. Thus, allowing a CCP donor to donate twice a month with maximum collection of 500 ml in each donation. At our institute, CCP collected is intended for transfusions only. During the initial phases of COVID-19 pandemic, CCP transfusions were performed as a part of clinical trial to evaluate its safety and efficacy. Later on, its use was restricted for off label indication or transfused on compassionate grounds. CCP donor eligibility criteria at our institution were in accordance with national guidelines issued by Indian Council of Medical Research (ICMR) [2] and National Blood Transfusion Council (NBTC) [3], India. Our donor eligibility criteria are as following: At our institution CCP donors are not tested for SARS-CoV-2 by PCR method to confirm clearance of the infection before donation. Yes, we do test the CCP donors for presence of IgG anti-SARS-CoV-2 antibodies using chemiluminescence assay in Abbott platform (i1000SR) before donation. We were using all the CCP above the cut-off recommended by the manufacturer (1·4) for differentiating positive and negative samples. Pre-donation testing of blood donors for presence of IgG anti-SARS-CoV-2 antibodies is being done and repeat testing of the collected units is not done. The unit is collected either on the same day of testing or the next day. As we did not have facility for testing neutralizing titre, we do store the frozen sample of CCP for testing in future. Pathogen reduction treatment for plasma is still not in use in our country, so collected CCP units were not subjected to pathogen reduction treatment. As per the regulations laid out in the Drug and Cosmetic Act (Second Amendment), 2020 [1], any blood and blood component recipient should be deferred for any donation until 12 months. Accordingly, we also do not accept recipients of CCP for convalescent plasma donation. At our institution, we accept whole blood or apheresis donation after 28 days of complete recovery after COVID-19 infection as per the guidelines issued by the National Blood Transfusion Council, India [3]. As per the regulations laid out in the Drug and Cosmetic Act (Second Amendment), 2020 [1], any blood and blood component recipient should be deferred for any donation until 12 months. Accordingly, we also do not accept recipients of CCP for whole blood and apheresis donation until 12 months after receipt of transfusion. Blood collection by apheresis is not a routine procedure in our country and is limited to only platelet collections at most of the blood centres. Thus, general public in our country is less aware and motivated towards blood component donations through apheresis procedure. Motivating individuals who have recently recovered from severe mental stress due to COVID-19 for apheresis donation was a daunting task. This was subdued by continuous motivation of potential donors, especially by treating clinicians during treatment or recovery and follow-up by the blood centre staff. Since recruiting donors for CCP donation was difficult amid the national lockdown, we had to modify our approach towards recruitment and screening of the blood donors. A telephonic screening of potential donors by asking the health related questions or sending questionnaire by digital means, allowed only the eligible donors to come at the blood centre. This not only reduced the hardships faced by the donors during travel restrictions but also helped in maintaining social distance. At times, incentivizing the donor in the form of transportation through hospital/medical vehicle, also aided them to come and donate CCP. Since plasma donation was new procedure for most donors, the total time taken for CCP donation, including waiting time required for testing and due to the limited apheresis equipment was also a demotivating factor for many donors. This was improved by allotting time slots for sample collection and procedure to donors and demarcating dedicated space and equipment for CCP donation. Apart from donor-related issues, we also faced issues related to the availability of quality antibody assays to screen donors for presence of SARS-CoV-2 antibodies. The availability of neutralizing assays remains a challenge. However, stringent CCP donor selection criterion remained a major hurdle in the overall process as it reduced the number of eligible donors significantly. A careful analysis of risk vs. benefit of certain less innocuous conditions in the donors and relaxing them, during the pandemic situation can further improve the overall recruitment of donors for CCP. Roberta Maria Fachini, Patrícia Scuracchio & Silvano Wendel The Hospital Sírio-Libanês is a not for profit private hospital with 510 in-patient beds that transfuses an average of 6000 red blood cells (RBCs)/year. The hospital receives paediatric and adult patients affected by clinical or surgical diseases. It is a national reference institution for oncological and critical patients, including those that need to be submitted to bone marrow transplantation, solid organ transplants, cardiovascular, orthopaedic, neurological and extensive oncological surgeries. The Hospital Sírio-Libanês Blood Bank collects approximately 5500 whole blood units and 1750 apheresis, rendering additional 2300 components per year. As no specific single therapeutic measure has been proven efficient for COVID-19 treatment yet, the transfusion of SARS-CoV-2 convalescent plasma (CCP) has been studied through clinical trials. Only male candidates, who had a moderate/mild disease, and full clinical recovery at least for ≥14 days, with a previous positive RT-PCR, age ranging from 18 to 60 years and body weight >55 kg were accepted as potential CCP donors, according to national guidelines [1, 2]. Those approved by a medical interview, were submitted to a second RT-PCR (whose result had to be negative), and had their neutralizing antibodies (nAb) tested by a virus neutralization test (VNT), and anti-nucleocapsid (NP) SARS-CoV-2 IgM, IgG and IgA ELISAs, as described elsewhere [3]. CCP units were collected only via plasmapheresis with a standard 600 mL plasma collection. According to Brazilian guidelines, each apheresis donor is allowed to donate plasma up to four times by apheresis in a two-month period; however, in specific situations, they can donate in shorter period in order to supply the transfusion demand for special patients, as COVID-19 [2]. All the collected CCP is intended for transfusion, mostly for clinical trials, and in lesser amount as compassionate use, depending on the medical request. For clinical trial use, admitted patients were confirmed by RT-PCR, being ≥18 years old, and with criteria for severe pneumonia (defined by respiratory distress: oxygen saturation of 93% or less on room air, respiratory rate >30 breaths/min and/or arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) of 300 or less). Patients with preexisting history of anaphylactic transfusion reaction, pregnant or lactating women were excluded from trials [4]. No CCP units were intended as prophylaxis or fractionation use at this moment. Donors had to present a previous positive molecular test (SARS-CoV-2 RT-PCR) collected by nasopharyngeal swab at the time of the diagnosis, and full clinical recovery for at least 14 days after the beginning of their symptoms. Donors approved by the medical examination underwent a second molecular test (SARS-CoV-2 RT-PCR by nasopharyngeal swab), which had to be non-reactive in order to be accepted for donation. Donors who remain reactive by the RT-PCR were invited to perform a third RT-PCR test after additional 14 days. If the subsequent RT-PCR test is non-reactive, the donor was accepted; otherwise, rejected from the CCP collection program [3]. Additionally, donors were tested for blood typing (ABO and RhD), irregular antibodies to red blood cell antigens (immunohematologic tests), and infectious diseases markers (hepatitis B and C virus, human immunodeficiency virus, human T-lymphotropic virus-1/2, syphilis and Chagas disease). Serum samples were collected for a cytopathic effect (CPE)-based virus neutralization test (VNT) carried out with SARS-CoV-2 (Gen-Bank: MT MT350282) and for immunoglobulins (IgA, IgM and IgG) nucleocapsid protein (NP)-based SARS-CoV-2 enzyme-linked immune-sorbent assays (ELISA) [3] at the moment of the first medical interview, together with the second RT-PCR. Only donors with nAb titre ≥160 and a negative RT-PCR were later accepted for donation, regardless of anti-NP results. Likewise, the same tests for anti-SARS-CoV-2 antibodies (nAbs and immunoglobulins) were carried out on donated CCP units, using the same criteria described above. All CCP units were treated with INTERCEPT® (Cerus Corporation, Concord, USA), according to manufacturer’s instructions, either individually or pooled two by two. After treatment, units are separated into 200 ml doses. Pre- and post-treatment samples were tested for nAb titres and specific anti-NP antibodies, with no considerable change both in nAb or anti-NP levels before or after pathogen reduction [5]. The answer is no, based on our current protocol, which establishes that only individuals who had mild/moderate SARS-CoV-2 infections can be candidate for donations. In addition, the Brazilian legislation [2], defines that anyone who has received a transfusion of any blood component, could donate blood only after a minimum period of 1 year. Yes, we accept individuals recovered from COVID-19 infection for standard whole blood or apheresis donation, as long as they have had the mild form of the disease and only after 60 days of complete recovery of all symptoms. See question 9. The implementation of a CCP collection program in our blood service was a very important action in order to provide specific immunological support therapy during the pandemic and to analyse the strengths and weaknesses of this program. One of the main concerns observed was the long persistence of RT-PCR positive for more than 28-day period in 30% of the CCP donors [3], which led us to decide extending the current 28-day to 60-day period for temporarily donor rejection after being infected by SARS-CoV-2. We have also observed that specific IgG antibodies might correlate with high nAb titres as well as an interesting direct relation between body mass index (BMI) and donor nAb titres, suggesting that overweight or obese donors have more capacity to produce higher nAb levels [6]. Another issue to be highlighted was the pathogen reduction treatment (PRT) in all CCP units, whose method was already implemented in our service. To date, PRT is not a national routine in Brazil, although considered an important method for coronavirus inactivation in blood components. The main challenge is still to define which patients would certainly benefit from this kind of therapy, since large RCT are quite difficult to be implemented in the country at this moment, despite the high number of COVID cases. Ai Leen Ang & Kiat Hoe Ong Singapore’s COVID-19 Convalescent Plasma (CCP) Programme was jointly developed by the National Centre for Infectious Diseases (NCID), Tan Tock Seng Hospital (TTSH) and Health Sciences Authority (HSA). HSA is a National Blood Establishment and TTSH is a tertiary hospital that operates a hospital-based blood transfusion and therapeutic apheresis service. While TTSH is not usually involved in blood collection, it has been specifically licensed to collect CCP for Singapore due to logistical reasons as it has close affiliations with NCID (Singapore’s main referral centre for COVID-19). TTSH is responsible for the selection of suitable CCP donors referred by NCID and the collection, storage and distribution of CCP in Singapore. HSA is responsible for establishing the general blood donation criteria (non-specific for CCP but still need to be fulfilled by CCP donors), freezing and standard donation testing (non-specific for CCP) of the CCP collected by TTSH. TTSH collects CCP by plasmapheresis. The donation frequency for CCP was initially aligned to that of routine plasma donation by apheresis at HSA, which was a maximum of 13 donations per year with at least 4-weeks interval between donations. To allow more frequent CCP collections from donors with high SARS-CoV-2 neutralizing antibody titre, the minimum inter-donation interval was subsequently changed to 2 weeks, provided that the donors’ serum albumin and globulin levels before each donation were in the reference range. Despite these changes, most CCP donors were only eligible to donate once or at most twice, mostly due to decreasing neutralizing antibody titres. Only one donor had antibody titres high enough to donate thrice. HSA has also established a process to convert suitable standard whole blood-derived plasma to CCP. This is meant to supplement the bulk of the CCP collected by plasmapheresis at TTSH. Male blood donors who have made standard whole blood donations will have their blood samples tested for SARS-CoV-2 neutralizing antibody titre if they declare a history of COVID-19 infection within the past 6 months. If their neutralizing antibody titres meet the minimum target, HSA will label their whole blood-derived plasma as CCP. The red cells and platelets from their whole blood donation will still be used for routine transfusion since they are accepted as standard whole blood donors for their donations. So far, there had not been any whole blood-derived plasma suitable for conversion to CCP as the neutralizing antibody titres tested were below the target level. These plasma units were labelled as standard frozen plasma and stored for routine transfusion. The CCP collected in Singapore is only for therapeutic transfusion as part of a monitored expanded access programme. It is not sent for fractionation. Besides the standard blood donation criteria, other donation criteria specific for CCP are: (Initially as a precaution, the donor’s blood sample needs to be negative for SARS-CoV-2 PCR before CCP is collected from them. There were plans to remove this requirement but no further CCP donors were screened when the number of eligible donors decreased dramatically since Sep 2020 due to the low number of new COVID-19 infections in Singapore. This requirement will be removed should there be subsequent screening of new CCP donors.) We currently do not test the CCP donor for SARS-CoV-2 by PCR before donation to confirm clearance of the infection. CCP donors would be tested for SARS-CoV-2 neutralizing antibody titre to ensure that they meet the minimum antibody titre before they are accepted for CCP donation by plasmapheresis at TTSH. The titre is performed by a lab at an academic institution (DUKE-NUS Medical School) which has developed the SARS-CoV-2 surrogate virus neutralization test (sVNT) based on antibody-mediated blockage of ACE2-spike protein–protein interaction [1]. The minimum surrogate neutralizing antibody titre was initially set as 40, but this was subsequently increased to 80 in early May 2020 when there were more potential CCP donors. At the time of CCP donation by plasmapheresis at TTSH, the donors’ blood samples are sent for SARS-CoV-2 neutralizing antibody titre again using the same method by the same lab stated in response to question 6. The CCP units collected would still be stored for future use even if the neutralizing antibody has fallen below the minimum titre of 80 at the time of donation. However, CCP units with higher titres of 80 and above would be prioritized for use. Samples from the CCP donation are archived for future assessment. For the conversion of suitable standard whole blood-derived plasma to CCP (see response to question 2 for details), the neutralizing antibody titre for SARS-CoV-2 is also determined using the same method by the same lab as stated in response to question 6. The minimum neutralizing antibody titre is 40 for the whole blood-derived plasma to qualify for conversion to CCP. As a routine practice, all of HSA’s standard blood donations would have an archived sample kept for up to 12 months post-donation. The CCP in Singapore is not pathogen reduced. Pathogen reduction technology is currently also not applied to the standard plasma in Singapore. Those who have received any type of blood transfusion (including CCP) would need to wait for 12 months before they can make any blood donation (including CCP). This is aligned to the standard blood donation criteria. Therefore, most patients would likely not qualify as CCP donor if they have received CCP since they would need to be deferred for 12 months after their CCP transfusion, by which time their neutralizing antibody titres will likely fall too low for them to be CCP donors. HSA accepts individuals who have recovered from COVID-19 infection for standard whole blood or apheresis donation, at least 28 days from clinical recovery. The definition of clinical recovery is the same as that for CCP donors (please see response to question 4 for details. HSA accepts recipients of CCP for standard whole blood or apheresis donation at least 12 months from their CCP transfusion. This is aligned to the standard blood donation criteria, which require a deferral of 12 months from any type of blood transfusion, including CCP. The collection of CCP by TTSH, which is closely affiliated with the main referral centre for COVID-19 in Singapore (NCID), helps to overcome several logistical challenges, such as identifying and recruiting suitable CCP donors. Close collaboration was needed between TTSH and HSA to establish the necessary processes and pro" @default.
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- W3159976957 date "2021-05-20" @default.
- W3159976957 modified "2023-10-17" @default.
- W3159976957 title "International Forum on the Collection and Use of COVID‐19 Convalescent Plasma: Responses" @default.
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- W3159976957 doi "https://doi.org/10.1111/vox.13114" @default.
- W3159976957 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/8242651" @default.
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