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Bioequivalence of Samchundang Lercanidipine Tablet 10 mg to Zanidip Tablet (Lercanidipine Hydrochloride 10 mg) by Liquid Chromatography with Tandem Mass Spectrometry

  • Kim, Se-Mi;Kim, Hwan-Ho;Shin, Sae-Byeok;Kang, Hyun-Ah;Cho, Hea-Young;Kim, Yoon-Gyoon;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.37 no.5
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    • pp.315-321
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    • 2007
  • The purpose of the present study was to evaluate the bioequivalence of two lercanidipine hydrochloride tablets, Zanidip tablet (LG Life Sciences Ltd., Korea, reference drug) and Samchundang Lercanidipine tablet 10 mg (Sam Chun Dang Pharm. Co. Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (amlodipine maleate) to human serum, serum samples were extracted using hexan-isoamyl alcohol (100:1, v/v). Compounds were analyzed by liquid chromatography/tandem mass spectrometry. This method showed linear response over the concentration range of 0.05-20 ng/mL with correlation coefficient of 0.9999. The lower limit of quantitation using 0.5 mL of serum was 0.05 ng/mL which was sensitive enough for pharmacokinetic studies. Thirty healthy male Korean volunteers received each medicine at the lercanidipine hydrochloride dose of 20 mg in a $2\;{\times}\;2$ crossover study. There was a one-week washout period between the doses. Serum concentrations of lercanidipine were monitored by an LC/MS/MS fer over a period of 24 hr after the administration. $AUC_t$ (the area under the serum concentration-time curve from time 0 to 24 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (the maximum serum drug concentration) and $T_{max}$ (the time to reach $C_{max}$) were compiled from the serum concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters, indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Samchundang Lercanidipine/Zanidip were log 0.9505-log 1.2258 and log 0.9987-log 1.2013, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Samchundang Lercanidipine tablet 10 mg and Zanidip tablet are bioequivalent.

Persistent Organic Pollution and Arsenic Contamination in Asia Pacific Water: Case Study of Emerging Environmental Problems in Vietnam

  • Pham, Viet.H.
    • Journal of Wetlands Research
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    • v.9 no.1
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    • pp.79-89
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    • 2007
  • This paper provides a comprehensive overview of the present status of several environmental problems caused by emerging toxic substances such as persistent organic pollutants (POPs), endocrine disrupting chemicals (EDCs), and arsenic in various environmental media in Vietnam. Monitoring data reported during the 1990s demonstrated elevated contamination of DDTs in most of these compartments in Vietnam. Studies in frame of the Asia-Pacific Mussel Watch Program revealed that fish, mussels and resident birds from Vietnam contained higher concentrations of DDTs as compared to other countries in region, suggesting the role of Vietnamese environment as a significant emission source of DDT in the Southeast Asian region. The estimated dietary intakes of PCBs and DDTs for Vietnamese were relatively high among Asian developing countries, suggesting potential risk for humans posed by thesechemicals. Widespread contamination of some endocrine active compounds such as alkylphenols and phthalates was observed at various sites along the coasts of northern and middle Vietnam. The presence of significant source of bisphenol-A along Red River estuary was revealed with the concentrations comparable to those reported for developed nations. A case study on seasonal variation of alkylphenols and phthalates in surface water of river delta and estuary of north and middle Vietnam indicated the differences in distribution of these compounds between dry and rainy seasons. Higher concentrations of alkylphenols and phthalates were found in dry season in estuary; while the contrasting pattern was observed in the river delta, showing elevated residues in rainy season. This result suggests the different behavior of alkylphenols and phthalates in river delta and coastal environment. From ecotoxicological perspectives, concentrations of bis-phenol A and di(2-ethylhexyl)phthalates [DEHP] in surface water from some locations in Vietnam exceeded the guideline values for Ecotoxicological Effects and the Environmental Risk Limit, respectively, suggesting potential for toxic implications on aquatic wildlife. Widespread and elevated arsenic contamination was discovered inour recent surveys in groundwater in a large area of suburban areas of Hanoi city, the capital of Vietnam. The most recent investigation in 4 villages showed about more than 50 % of groundwater samples contained As concentrations exceeding 50 g/L (the WHO and Vietnamese standard). In particular, in Son Dong villages, 58 % of samples analyzed contained As concentrations higher than 200 g/L. Good correlations were found in As concentrations in water and hair and urine of peoples in corresponding families, suggesting the chronic exposure to As by people living in As-contaminated ground water areas. In Son Dong village, As levels in hair (mean: 1.7 mg/kg dry wt) and urine (g/g creatinine) exceeding the reference values recommended by WHO, suggesting potential for human risk posed by long term accumulation of As in human body. Future studies should be focused on the time trends of POPs and EDCs in biota in Vietnam in order to predict future trend of contamination and to reveal new clues for understanding possible toxic impacts on aquatic organisms. The issues of arsenic contamination in groundwater and their chronic toxic implications on human health should be systematically investigated in the future.

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A Study on the Performance of Noise Level and Airflow Amount of a Kitchen Hood by the Different Conditions of Airflow Path. (레인지후드 덕트설치 조건에 따른 소음 및 풍량특성 연구)

  • Kim, Il-Ho;Kim, Youn-Jae;Lee, Yong-Jun;Lee, Kyu-Dong
    • Proceedings of the Korean Institute of Building Construction Conference
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    • 2007.11a
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    • pp.11-14
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    • 2007
  • Noise level and Airflow amount of a kitchen hood are affected by the conditions of airflow path. Thus this study is expected to be used as a basic reference in designing airflow path of apartment housing throughout analysing changes in noise level and airflow amount from the various conditions of airflow path. Noise level generated by the kitchen hood is estimated in a kitchen and a living room of two constructed apartment houses, and an experiment is conducted in an half anechoic chamber to analyze noise level and airflow amount by the different length, diameter and number of windings of a round shaped soft duct which is connected to the kitchen hood. The measured results in apartment houses show that the noise level in both apartments exceeds the NC standard greatly in living spaces. In apartment A, a regular apartment house, the noise level was $NC-65{\sim}75$, $NC-45{\sim}60$ and NC-70, NC-45 in the kitchen and living room with an operation of kitchen hood in 1 and 3 stages. In apartment B, an apartment complex, the noise level was NC-55 and NC-60 in the kitchen and living room with an operation of kitchen hood in 3 stages. In particular, there was an increase of noise level at 125Hz-band resulted from an amplification of sound, which requires adequate measures in noise reduction. The results measured in Half anechoic chamber show 99% of airflow amount increase with the modification of a duct' s diameter from ${\Phi}$ 100mm to ${\Phi}$ 125mm, 37% of airflow amount increase with the modification of a duct' s diameter from ${\Phi}$ 125mm to ${\Phi}$ 150mm, and 173% of airflow amount increase with the modification of a duct' s diameter from ${\Phi}$ l00mm to ${\Phi}$ 150mm. The noise level was lower than the level measured in apartment housing about 20 in NC-value and 11.4 in dB(A)-value, which was interpreted as the effect of the load by the pressure condition at the rear end of the duct. Also, an amplification of sound in 125Hz-band influenced NC-value considerably, therefore effective measure is needed.

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Near infrared spectroscopy for classification of apples using K-mean neural network algorism

  • Muramatsu, Masahiro;Takefuji, Yoshiyasu;Kawano, Sumio
    • Proceedings of the Korean Society of Near Infrared Spectroscopy Conference
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    • 2001.06a
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    • pp.1131-1131
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    • 2001
  • To develop a nondestructive quality evaluation technique of fruits, a K-mean algorism is applied to near infrared (NIR) spectroscopy of apples. The K-mean algorism is one of neural network partition methods and the goal is to partition the set of objects O into K disjoint clusters, where K is assumed to be known a priori. The algorism introduced by Macqueen draws an initial partition of the objects at random. It then computes the cluster centroids, assigns objects to the closest of them and iterates until a local minimum is obtained. The advantage of using neural network is that the spectra at the wavelengths having absorptions against chemical bonds including C-H and O-H types can be selected directly as input data. In conventional multiple regression approaches, the first wavelength is selected manually around the absorbance wavelengths as showing a high correlation coefficient between the NIR $2^{nd}$ derivative spectrum and Brix value with a single regression. After that, the second and following wavelengths are selected statistically as the calibration equation shows a high correlation. Therefore, the second and following wavelengths are selected not in a NIR spectroscopic way but in a statistical way. In this research, the spectra at the six wavelengths including 900, 904, 914, 990, 1000 and 1016nm are selected as input data for K-mean analysis. 904nm is selected because the wavelength shows the highest correlation coefficients and is regarded as the absorbance wavelength. The others are selected because they show relatively high correlation coefficients and are revealed as the absorbance wavelengths against the chemical structures by B. G. Osborne. The experiment was performed with two phases. In first phase, a reflectance was acquired using fiber optics. The reflectance was calculated by comparing near infrared energy reflected from a Teflon sphere as a standard reference, and the $2^{nd}$ derivative spectra were used for K-mean analysis. Samples are intact 67 apples which are called Fuji and cultivated in Aomori prefecture in Japan. In second phase, the Brix values were measured with a commercially available refractometer in order to estimate the result of K-mean approach. The result shows a partition of the spectral data sets of 67 samples into eight clusters, and the apples are classified into samples having high Brix value and low Brix value. Consequently, the K-mean analysis realized the classification of apples on the basis of the Brix values.

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COMPARISON OF LINEAR AND NON-LINEAR NIR CALIBRATION METHODS USING LARGE FORAGE DATABASES

  • Berzaghi, Paolo;Flinn, Peter C.;Dardenne, Pierre;Lagerholm, Martin;Shenk, John S.;Westerhaus, Mark O.;Cowe, Ian A.
    • Proceedings of the Korean Society of Near Infrared Spectroscopy Conference
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    • 2001.06a
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    • pp.1141-1141
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    • 2001
  • The aim of the study was to evaluate the performance of 3 calibration methods, modified partial least squares (MPLS), local PLS (LOCAL) and artificial neural network (ANN) on the prediction of chemical composition of forages, using a large NIR database. The study used forage samples (n=25,977) from Australia, Europe (Belgium, Germany, Italy and Sweden) and North America (Canada and U.S.A) with information relative to moisture, crude protein and neutral detergent fibre content. The spectra of the samples were collected with 10 different Foss NIR Systems instruments, which were either standardized or not standardized to one master instrument. The spectra were trimmed to a wavelength range between 1100 and 2498 nm. Two data sets, one standardized (IVAL) and the other not standardized (SVAL) were used as independent validation sets, but 10% of both sets were omitted and kept for later expansion of the calibration database. The remaining samples were combined into one database (n=21,696), which was split into 75% calibration (CALBASE) and 25% validation (VALBASE). The chemical components in the 3 validation data sets were predicted with each model derived from CALBASE using the calibration database before and after it was expanded with 10% of the samples from IVAL and SVAL data sets. Calibration performance was evaluated using standard error of prediction corrected for bias (SEP(C)), bias, slope and R2. None of the models appeared to be consistently better across all validation sets. VALBASE was predicted well by all models, with smaller SEP(C) and bias values than for IVAL and SVAL. This was not surprising as VALBASE was selected from the calibration database and it had a sample population similar to CALBASE, whereas IVAL and SVAL were completely independent validation sets. In most cases, Local and ANN models, but not modified PLS, showed considerable improvement in the prediction of IVAL and SVAL after the calibration database had been expanded with the 10% samples of IVAL and SVAL reserved for calibration expansion. The effects of sample processing, instrument standardization and differences in reference procedure were partially confounded in the validation sets, so it was not possible to determine which factors were most important. Further work on the development of large databases must address the problems of standardization of instruments, harmonization and standardization of laboratory procedures and even more importantly, the definition of the database population.

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A Short-term Longitudinal Study of Depression and Life Satisfaction of the Elderly: Focusing on Living Arrangement (여성 노인의 거주형태에 따른 우울과 삶의 만족도에 대한 단기종단연구)

  • Jeon, Byeong Joo
    • 한국노년학
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    • v.37 no.4
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    • pp.853-870
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    • 2017
  • This study examined the changes of depression and life satisfaction among the elderly living together in group-home and congregate housing. And in this course, it was to verify the practical effects of the recent government and local authority community life of elderly people by comparing them with the groups of elders living alone. The study was divided into Time 1 and Time 2, and 205 person's data were used for the final analysis. PASW Statistics 18.0 was utilized to analysis the data of this study, because it is difficult to explain the results of this analysis, secondary qualitative research has been used to identify additional contextual information. The major results of this study are as follows. First, the depression of the subjects was significantly improved in the case of living in group-home and congregate housing, and it was significantly worse in the group of elders living alone. Second, the life satisfaction of survey subjects was significantly improved when living in congregate housing, group-home was significantly worse, and the group of elders living alone were not statistically significant but slightly worse. Third, mixed research methods were applied to make accurate interpretation of changes of life satisfaction of the elderly living in group-home. Based on the results of this study, it is possible to establish appropriate measures for the elderly to improve early adjustment and quality of life in community life. And the community life of the elderly can contribute to a real social safety net by solving the blind spot of welfare. At the national level, it can be utilized as a standard reference to improve and strengthen existing policies by providing data that can simultaneously examine the performances and problems of various policies related to housing or the welfare of the elderly.

Case Study on Treaty-Based Investor-State Arbitration and Environmental Litigations with Specific Reference to Chevron/Ecuador Litigation (환경 소송과 국제투자중재 - 쉐브론 사건을 중심으로)

  • Kang, Pyoung-Keun
    • Journal of Arbitration Studies
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    • v.25 no.4
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    • pp.3-23
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    • 2015
  • The Chevron saga including Chevron/TexPet v. Ecuador, PCA Case No. 34877(hereinafter referred to as "Chevron I") and Chevron/TexPet v. Ecuador, PCA Case No. 2009-23(hereinafter referred to as "Chevron II") started out of domestic litigations between TexPet and Ecuador in the early 1990s. In Chevron I, the Tribunal decided that Article 2(7) of the U.S.-Ecuador BIT on effective means of provision was breached because of undue delays in the seven legal proceedings TexPet had brought against Ecuador in respect to contractual obligations. In Chevron II, it was contended that through the actions and inactions of the judiciary and the executive, Ecuador breached her several obligations under the BIT. Ecuador objected to the jurisdiction of the Tribunal because TexPet's investment was terminated in 1992, and because Chevron is not a party to the 1995 Settlement Agreement and 1998 Final Release. In its Interim Award on Jurisdiction and Admissibility, the Tribunal applied a prima facie standard to the facts alleged by the Claimants but denied by the Respondent, and decided that questions in respect of the Respondent's jurisdictional objections should be joined to the merits under Article 21(4) of the UNCITRAL Arbitration Rules. In the merits phase of Chevron II, the Tribunal divided the merits of the Parties' dispute into two parts, entitled "Track 1" and "Track 2". In its Partial Award on Track 1, the Tribunal decided that Chevron is a "Releasee" under the 1995 Settlement Agreement. In a decision on "Track 1B", the Tribunal decided that the Lago Agrio complaint cannot be read as pleading "exclusively" or "only" diffuse claims, and that, to this extent, the Claimants' reliance on the 1995 Settlement Agreement as a complete bar to the Lago Agrio complaint must fail, as a matter of Ecuadorian law. The Tribunal maintained the position that the Parties' disputes on both merit and jurisdiction should be reserved for Track 2. It remains to be seen how the Tribunal addresses the Claimants' allegations of multiple denials of justice under international law against the judgments of the Respondent's Courts, together with the Respondent's jurisdictional objections in Track 2 of the arbitration.

Chromatic adaptation model for the variations of the luminance of the same chromaticity illuminants (동일 색도 광원의 휘도 변화에 따른 색 순응 모델)

  • Kim Eun-Su;Jang Soo-Wook;Lee Sung-Hak;Sohng Kyu-lk
    • Journal of the Institute of Electronics Engineers of Korea SP
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    • v.42 no.4 s.304
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    • pp.31-38
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    • 2005
  • In this paper, we propose the chromatic adaptation models (CAM) for the variations of the luminance levels. A chromatic adaptation model, CAM$\Delta$Y , is proposed according to the change of luminance level under the same illuminants. The proposed model is obtained by the transform the test colors of the high luminance into the corresponding colors of the low luminance. In the proposed model, the optimal coefficients are obtained from the corresponding colors data of the Breneman's experiments. In the experimental results, we confined that the chromaticity errors, $\Delta$u'v', between the predicted colors by the proposed model and the corresponding colors of the Breneman's experiments are 0.004 in u'v' chromaticity coordinates. The prediction performance of the proposed model is excellent because this error is the threshold value that two adjacent color patches can be distinguished. Additionally, we also propose equal-whiteness CCT curves (EWCs) by CAM$\Delta$Y according to the luminance levels of the surround viewing conditions. And the proposed EWCs can be used as the theoretical standard which determines the reference white of the color display devices.

An Electrophysiologic Study on the Ulnar Digital Nerves (척골 지단 신경의 전기생리학적 연구)

  • Kim, Jong-Soon;Lee, Hyun-Ok;Ahn, So-Youn;Koo, Bong-Oh;Nam, Kun-Woo;Kim, Ho-Bong;Ryu, Jae-Kwan;Ryu, Jae-Moon
    • The Journal of Korean Academy of Orthopedic Manual Physical Therapy
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    • v.11 no.2
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    • pp.13-18
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    • 2005
  • The ulnar nerve extends down the arm, across the elbow, and into the hand. It provides sensation to the little and ring fingers and activates many of the small muscles in the hand. The determination of peripheral nerve conduction velocity is an important part of ulnar nerve evaluation. The electrodiagnostic value as neurophysiologic investigative procedure has been known for many years but normal value of digital nerve was not reported in Korea. The purpose of this investigation was to measure the digital nerve conduction velocity of ulnar nerve for obtain clinically useful reference value and compare difference in each fingers and then compare with the other countries. 71 normal Korean volunteers (age, 19-65 years; 142 hands) examined who has no history of peripheral neuropathy, diabetic mellitus, chronic renal failure, endocrine disorders, anti-cancer medicine, anti-tubercle medicine, alcoholism, trauma, radiculopathy. Nicolet Viking II (EMG machine) was use for detected conduction velocity and amplitude of digital nerves in ulnar nerve. Data analysis was performed using SPSS. Descriptive analysis was used for obtain mean and standard deviation and independent t-test was used to compare with ring and little finger. Conduction velocity of the right ring finger was 57.44m/sec and little finger was 55.32msec. The left ring finger was 55.55msec and little finger was 54.11msec. Amplitude of the right ring finger was $30.28{\mu}V$ and little finger was $48.36{\mu}V$. The left ring finger was $30.67{\mu}V$ and little finger was $52.76{\mu}V$. There were significantly difference between ring and little in amplitude (p<.05) but there were no statistically difference between conduction velocity of ring and little finger (p>.05). The amplitude of little finger are greater than ring finger. The present results revealed that electodiagnosis can easily perform in little finger for digital nerve of ulnar nerve study.

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Correlation Between Social Distancing Levels and Nighttime Light (NTL) during COVID-19 Pandemic in Seoul, South Korea Based on The Day-Night Band (DNB) Onboard The Suomi National Polar-Orbiting Partnership (S-NPP) Satellite (코로나19 팬데믹 기간의 서울의 사회적 거리두기 단계 변화와 The Suomi National Polar-Orbiting Partnership (S-NPP) 위성 영상을 이용한 Nighttime Light (NTL) 간의 상관관계)

  • Nur, Arip Syaripudin;Lee, Seulki;Ramayanti, Suci;Han, Ju
    • Korean Journal of Remote Sensing
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    • v.37 no.6_1
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    • pp.1647-1656
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    • 2021
  • In order to reduce the spread of infection due to COVID-19, South Korea has established a four-step social distancing standard and implemented it by changing the steps based on the rate of confirmed cases. The implementation of social distancing brought about a change in the amount of activity of citizens by limiting social contact such as movement and gathering of people. One of the data that can intuitively confirm this is Night Time Light (NTL). NTL is a variable that can measure the size of the national economy measured using lights captured by satellites, and can be used to understand people's social activities during the night. The NTL visible data is obtained via the Visible Infrared Imaging Radiometer Suite (VIIRS) Day-Night Band (DNB) onboard the Suomi National Polar-orbiting Partnership (S-NPP) satellite. 1023 of Suomi data from 1 January 2019 until 26 October 2021 were collected to generate time series of NTL radiance change over Seoul to analyze the correlation with social distancing policy. The results show that implementing the level of social distancing generally decreased the NTL radiance both in spatial disparities and temporal patterns. The higher level of policy, limiting human activities combined with the low number of people who have been vaccinated and the closure of various facilities. Because of social distancing, the differences in human activities affected the nighttime light during the COVID-19 pandemic, especially in Seoul, South Korea. Therefore, this study can be used as a reference for the government in evaluating and improving policies related to efforts reducing the transmission of COVID-19.