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巴西有媒體報道,中國科興生物研發的新型冠狀病毒(SARS-CoV-2)疫苗,有效率不足60%,雖超過世衛的50%標準,但低於早前傳出近80%有效率。

巴西與科興合作進行疫苗臨床試驗的聖保羅Butantan生物醫學中心,預定在當地時間1月12日中午時間公布詳細測試結果。巴西新聞網UOL引述已閱讀報告的消息人士報道,科興疫苗的有效率只介乎50%至60%之間
Butantan生物醫學中心回應時否定有關報道,指任何傳聞的疫苗有效率消息都不準確,他們將在12日公開報告及結果。

在較早前,有巴西研究人員曾表示科興疫苗有78%的有效率,同時有完全阻止病情惡化至嚴重的能力。印尼在11日亦宣布,指根據臨床測試,科興疫苗有65%的有效率。

世衛訂立的疫苗門檻有效率為50%,一般相信科興疫苗能超過此最低門檻,但未知正式結果為多少。目前已公布的疫苗有效率中,以輝瑞疫苗、莫德納及俄羅斯衛星-V疫苗有超過90%的有效率,英國阿斯利康與牛津共同研發的疫苗有效率為70%。


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我真係唔知點解科學研究、測試、公佈數據都可以攪到咁撲索迷離。有人話睇過報告,得50%-60%,但有關當局又否認報導,咁遲少少若然公佈話有效率最終審定為90%,我信唔信好呢?

新聞來源連結:
https://www.hk01.com/即時國際/573212/新冠肺炎-巴西即將公布科興疫苗測試結果-媒體稱有效率不足60



熱賣及精選
打左作用不大


身體最誠實


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原帖由 六嬸嬸 於 2021-1-12 02:52 PM 發表

身體最誠實
X100......



Macau.........I don`t care..

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引用:
原帖由 hfceddie 於 2021-1-12 02:48 PM 發表


https://cdn.hk01.com/di/media/images/dw/20210112/425635419762200576602384.jpeg/oREDrpwjtco4R9H9POjcDUfYb7eEy72HwtT-isLU_oo

巴西有媒體報道,中國科興生物研發的新型冠狀病毒(SARS-CoV-2)疫苗,有效率不足60%,雖超過世衛的50%標準,但低於早前傳出近80%有效率。
...
醫學雜誌踢爆輝瑞實際有效率只係29%....

https://big5.ftchinese.com/story/001090962?topnav=china

曹辛:《英國醫學雜誌》副主編彼得•多西對輝瑞疫苗實驗方法的質疑,令人懷疑是否政治與商業考慮衝擊了科學。
更新於2021年1月11日 07:37 察哈爾學會國際輿情研究中心秘書長 曹辛 為FT中文網撰稿

本欄目由FT中文網與公眾號「遠見經緯」(原公眾號「經緯遠見」)、中華智庫基金會共同主辦

註:本文醫學顧問:杜玉平,世界衛生組織前高級醫學官員

上周,在世界輿論普遍將重點放在特朗普的支持者佔領美國國會,並一律地加以譴責和討伐時,也有一個極其重要、應得到充分關注的輿情,事關當前全球抗疫的成敗。

這就是:有證據顯示,輝瑞和Moderna疫苗對人類抵抗新冠病毒的保護率遠不是美國特朗普政府和該企業公布的95%,而很可能是29%,這遠低於美國藥監局設定的50%的最低標準。

這個結論是建立在輝瑞已公布的部分數據基礎上的;同時,輝瑞對一些細節和原始數據公布得很少,這也增強了對其懷疑的論點。考慮到輝瑞疫苗是在低於一般科學規律的短時間內開發出來的,特朗普政府對其的大力支持也是關鍵因素之一,再加上當前世界其他大國的疫苗研發行為,我們有理由問:人類挽留自己生命的抗疫,正在走向全球性「政治掛帥」和「多快好省」之路?

對輝瑞統計方法的質疑

這個問題是《英國醫學雜誌》副主編彼得•多西揭發出來的。他的結論實際上是說:輝瑞疫苗的研發人員通過明顯違反科學原理的統計方法,即未依據原始數據,造出了輝瑞疫苗95%的、讓人放心的高保護率。或者換句話說:輝瑞疫苗對新冠病毒95%高保護率的可信度,是通過違反科學原理的統計方法得出的結論。

彼得•多西1月4日在《英國醫學雜誌》上撰寫文章,對上述問題做了下列介紹:

全世界所有目光都集中在了輝瑞新冠疫苗優異的保護率上:參與臨床試驗的志願者一共報告了170例經實驗室PCR檢驗確診的Covid-19病例,疫苗組和安慰劑組分別為8和162例。但病例定義中的疑似Covid-19病例(suspected cases),就是那些有Covid-19病毒感染症狀但未經實驗室PCR確診的病人,佔比太高,這使得所謂「高保護率」有些大打折扣。根據美國食品藥品監督局(FDA)關於輝瑞疫苗的報告,「在全部研究的志願者中,總共有3410例疑似Covid-19病例而未確診,疫苗組發生1594例,安慰劑組發生1816例。」

文章認為:「疑似病例是確診病例的20倍難以置信,疑似病例這一類病人不能簡單地被實驗室PCR檢測為陰性而不算作病人。對疫苗保護率的一個簡單估計是:無論PCR檢測與否,凡是有症狀的都應計算為病人,這樣的話其保護率則為19%,遠遠低於美國藥監局設定的最低保護率為50%的達標門檻。再進一步細分,去掉疫苗接種後7天內發生的病例(輝瑞的接種疫苗組409人,安慰劑組287人,這部分人由於疫苗尚未發揮作用以及接種疫苗副反應可以引起類似的副反應導致),其疫苗保護率才為29%。
據彼得•多西介紹,還有一個也很能說明問題的事實是:輝瑞疫苗的371名志願者在統計中被無故剔出在了保護率分析之外。

文章指出,我們需要更多原始數據的另一個原因是:美國FDA對輝瑞疫苗評審表中一個細節令人無法解釋,即有371名志願者因「第2針注射後第7天或7天內與臨床研究方案出現重大偏差」被排除在了保護率的計算之外。「更令人擔憂的是,被排除的志願者人數分布不均衡、不隨機,即疫苗組有311人,安慰劑組有60人被剔出。」相比之下,在Moderna的試驗中,只有36名志願者因與「主要臨床方案出現偏差」而被排除在保護率分析之外——即疫苗組12人,安慰劑組24人。

彼得•多西質問:在輝瑞的研究中,這些「與臨床研究方案偏差」具體指的是什麼?為什麼在疫苗組中有比安慰劑組中5倍以上的參與者被排除在統計分析外?據介紹,美國FDA的報告對此並沒有說明,這些被剔出的志願者在輝瑞的報告以及後來發表的文獻中也沒有披露。

以上立場,受到多年從事公共衛生工作的人士、製藥界人士和世界衛生組織人士的認同。他們告訴筆者:美國食品藥品監督局和輝瑞的統計方法,有嚴重問題。他們認為,應該將有新冠病毒發病狀況但難以檢測出感染的人列為病人,這樣的統計才準確;而且輝瑞這裡這樣的人太多了,疑似患者是確診人數的20倍,若不列入則無法準確判斷疫苗的可靠保護率。

「政治掛帥」?

考慮到美國疫情的嚴重性,以及特朗普當時也迫切有意把疫苗作為大選政績這兩大背景,人們有理由問:美國國家食品藥品監督局當初在批準輝瑞疫苗時,究竟是依據什麼科研標準批準輝瑞疫苗上市的?有沒有受到美國政府的政治壓力?同時,考慮到輝瑞疫苗是在大大縮短了研發的常規時間內開發出來的,幾乎用了不到一年的時間,而一般疫苗需要數年時間,人們就很難不這樣考慮問題了。

不過值得一提的是,中國的做法倒是截然相反:中國是把有感染症狀但檢查不出來的病歷作為「假陰性」,把沒有症狀的感染者作為「無症狀感染者」,一律作為病人收容入院治療或觀察的,因為這些人很可能會感染他人。當時國際上有國際組織和人士認為這種做法很過分,但今天來看,這比輝瑞和美國食品藥品監督局的做法,認真、負責得多。

輝瑞和美國食品藥品監督局這種類似的疫苗開發情況,當前在別的國家也同樣發生了,共同的表現是:不公布準確的實驗數據甚至不公布數據;開發技術不明或者用老技術;技術障礙導致疫苗對人類的核心後遺症無法解決等等。這一切不由得讓人想起「政治掛帥」和「多快好省」這類現代政治的常用操作方式了。那麼,科學呢?

對於《英國醫學雜誌》和部分國際科學家、專業人士提出的輝瑞疫苗的上述問題,輝瑞公司和美國食品藥品監督局有義務回答全世界的公眾。有人說:那為什麼世界衛生組織要推薦輝瑞疫苗呢?經筆者向有關人士了解,回答是:世界衛生組織推薦這款疫苗是因為美國食品和藥品監督局的批準,世衛組織不負責檢查原始數據。

《英國醫學雜誌》認為:如果許多或大多數疑似病例發生在PCR檢測結果為假陰性的人群中,這將大大降低疫苗的有效性。

該雜誌還提出建議:如果那些經歷疑似Covid-19患者的臨床歷程與確診Covid-19的人基本相同,那麼採用「疑似+確診Covid-19」(的統計方法)可能比「確診Covid-19」更有臨床意義。



隔離戴FULL GEAR既是否鬼..
派裝備那位是否係鬼...
派八達通,禮卷那個人是否又係鬼..
TELEGRAM內又有多少係鬼..
朋友被捉,會唔會篤灰,
戴口罩可能係鬼..唔戴又怕被人起底..
巴西受巴西侵侵搞搞震,唔使睇!


呢單新聞香港傳媒暫時好似得香港01有報導。


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引用:
原帖由 hw1chan 於 2021-1-12 02:50 PM 發表

打左作用不大
好過輝瑞,
有嚴重副作用...



隔離戴FULL GEAR既是否鬼..
派裝備那位是否係鬼...
派八達通,禮卷那個人是否又係鬼..
TELEGRAM內又有多少係鬼..
朋友被捉,會唔會篤灰,
戴口罩可能係鬼..唔戴又怕被人起底..

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老實講如果香港關口正常,上面落來D人會打邊種疫苗?心裡有數


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即係全部都無謂打


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https://blogs.bmj.com/bmj/2021/0 ... s-and-the-raw-data/


Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—we need more details and the raw data
January 4, 2021

Five weeks ago, when I raised questions about the results of Pfizer’s and Moderna’s covid-19 vaccine trials, all that was in the public domain were the study protocols and a few press releases. Today, two journal publications and around 400 pages of summary data are available in the form of multiple reports presented by and to the FDA prior to the agency’s emergency authorization of each company’s mRNA vaccine. While some of the additional details are reassuring, some are not. Here I outline new concerns about the trustworthiness and meaningfulness of the reported efficacy results.

“Suspected covid-19”

All attention has focused on the dramatic efficacy results: Pfizer reported 170 PCR confirmed covid-19 cases, split 8 to 162 between vaccine and placebo groups. But these numbers were dwarfed by a category of disease called “suspected covid-19”—those with symptomatic covid-19 that were not PCR confirmed. According to FDA’s report on Pfizer’s vaccine, there were “3410 total cases of suspected, but unconfirmed covid-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.”

With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. Indeed this makes it all the more urgent to understand. A rough estimate of vaccine efficacy against developing covid-19 symptoms, with or without a positive PCR test result, would be a relative risk reduction of 19% (see footnote)—far below the 50% effectiveness threshold for authorization set by regulators. Even after removing cases occurring within 7 days of vaccination (409 on Pfizer’s vaccine vs. 287 on placebo), which should include the majority of symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains low: 29% (see footnote).

If many or most of these suspected cases were in people who had a false negative PCR test result, this would dramatically decrease vaccine efficacy. But considering that influenza-like illnesses have always had myriad causes—rhinoviruses, influenza viruses, other coronaviruses, adenoviruses, respiratory syncytial virus, etc.—some or many of the suspected covid-19 cases may be due to a different causative agent.

But why should etiology matter? If those experiencing “suspected covid-19” had essentially the same clinical course as confirmed covid-19, then “suspected plus confirmed covid-19” may be a more clinically meaningful endpoint than just confirmed covid-19.

However, if confirmed covid-19 is on average more severe than suspected covid-19, we must still keep in mind that at the end of the day, it is not average clinical severity that matters, it’s the incidence of severe disease that affects hospital admissions. With 20 times more suspected covid-19 than confirmed covid-19, and trials not designed to assess whether the vaccines can interrupt viral transmission, an analysis of severe disease irrespective of etiologic agent—namely, rates of hospitalizations, ICU cases, and deaths amongst trial participants—seems warranted, and is the only way to assess the vaccines’ real ability to take the edge off the pandemic.

There is a clear need for data to answer these questions, but Pfizer’s 92-page report didn’t mention the 3410 “suspected covid-19” cases. Nor did its publication in the New England Journal of Medicine. Nor did any of the reports on Moderna’s vaccine. The only source that appears to have reported it is FDA’s review of Pfizer’s vaccine.

The 371 individuals excluded from Pfizer vaccine efficacy analysis

Another reason we need more data is to analyse an unexplained detail found in a table of FDA’s review of Pfizer’s vaccine: 371 individuals excluded from the efficacy analysis for “important protocol deviations on or prior to 7 days after Dose 2.”  What is concerning is the imbalance between randomized groups in the number of these excluded individuals: 311 from the vaccine group vs 60 on placebo. (In contrast, in Moderna’s trial, there were just 36 participants excluded from the efficacy analysis for “major protocol deviation”—12 vaccine group vs 24 placebo group.)

What were these protocol deviations in Pfizer’s study, and why were there five times more participants excluded in the vaccine group?  The FDA report doesn’t say, and these exclusions are difficult to even spot in Pfizer’s report and journal publication.

Fever and pain medications, unblinding, and primary event adjudication committees

Last month I expressed concern about the potential confounding role of pain and fever medications to treat symptoms. I posited that such drugs could mask symptoms, leading to underdetection of covid-19 cases, possibly in greater numbers in people who received the vaccine in an effort to prevent or treat adverse events. However, it seems their potential to confound results was fairly limited: although the results indicate that these medicines were taken around 3–4 times more often in vaccine versus placebo recipients (at least for Pfizer’s vaccine—Moderna did not report as clearly), their use was presumably concentrated in the first week after vaccine use, taken to relieve post-injection local and systemic adverse events. But the cumulative incidence curves suggest a fairly constant rate of confirmed covid-19 cases over time, with symptom onset dates extending well beyond a week after dosing.

That said, the higher rate of medication use in the vaccine arm provides further reason to worry about unofficial unblinding. Given the vaccines’ reactogenicity, it’s hard to imagine participants and investigators could not make educated guesses about which group they were in.  The primary endpoint in the trials is relatively subjective making unblinding an important concern. Yet neither FDA nor the companies seem to have formally probed the reliability of the blinding procedure, and its effects on the reported outcomes.

Nor do we know enough about the processes of the primary event adjudication committees that counted covid-19 cases. Were they blinded to antibody data and information on patients’ symptoms in the first week after vaccination?  What criteria did they employ, and why, with a primary event consisting of a patient-reported outcome (covid-19 symptoms) and PCR test result, was such a committee even necessary? It’s also important to understand who was on these committees. While Moderna has named its four-member adjudication committee—all university-affiliated physicians—Pfizer’s protocol says three Pfizer employees did the work. Yes, Pfizer staff members.



隔離戴FULL GEAR既是否鬼..
派裝備那位是否係鬼...
派八達通,禮卷那個人是否又係鬼..
TELEGRAM內又有多少係鬼..
朋友被捉,會唔會篤灰,
戴口罩可能係鬼..唔戴又怕被人起底..

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Vaccine efficacy in people who already had covid?
Individuals with a known history of SARS-CoV-2 infection or previous diagnosis of Covid-19 were excluded from Moderna’s and Pfizer’s trials. But still 1125 (3.0%) and 675 (2.2%) of participants in Pfizer’s and Moderna’s trials, respectively, were deemed to be positive for SARS-CoV-2 at baseline.
Vaccine safety and efficacy in these recipients has not received much attention, but as increasingly large portions of many countries’ populations may be “post-Covid,” these data seem important—and all the more so as the US CDC recommends offering vaccine “regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection.” This follows on from the agency’s conclusions, regarding Pfizer’s vaccine, that it had ≥92% efficacy and “no specific safety concerns” in people with previous SARS-CoV-2 infection.
By my count, Pfizer apparently reported 8 cases of confirmed, symptomatic Covid-19 in people positive for SARS-CoV-2 at baseline (1 in the vaccine group, 7 in the placebo group, using the differences between Tables 9 and 10) and Moderna, 1 case (placebo group; Table 12).
But with only around four to 31 reinfections documented globally, how, in trials of tens of thousands, with median follow-up of two months, could there be nine confirmed covid-19 cases among those with SARS-CoV-2 infection at baseline? Is this representative of meaningful vaccine efficacy, as CDC seems to have endorsed? Or could it be something else, like prevention of covid-19 symptoms, possibly by the vaccine or by the use of medicines which suppress symptoms, and nothing to do with reinfection?
We need the raw data
Addressing the many open questions about these trials requires access to the raw trial data. But no company seems to have shared data with any third party at this point.
Pfizer says it is making data available “upon request, and subject to review.” This stops far short of making data publicly available, but at least leaves the door open. How open is unclear, since the study protocol says Pfizer will only start making data available 24 months after study completion.
Moderna’s data sharing statement states data “may be available upon request once the trial is complete.” This translates to sometime in mid-to-late 2022, as follow-up is planned for 2 years.
Things may be no different for the Oxford/AstraZeneca vaccine which has pledged patient-level data “when the trial is complete.” And the ClinicalTrials.gov entry for the Russian Sputnik V vaccine says there are no plans to share individual participant data.
The European Medicines Agency and Health Canada, however, may share data for any authorized vaccines much earlier.  EMA has already pledged to publish the data submitted by Pfizer on its website “in due course,” as has Health Canada.
Peter Doshi, associate editor, The BMJ
Competing interests: I have been pursuing the public release of vaccine trial protocols, and have co-signed open letters calling for independence and transparency in covid-19 vaccine related decision making.
Footnote
Calculations in this article are as follows:  19% = 1 – (8+1594)/(162+1816); 29% = 1 – (8 + 1594 – 409)/(162 + 1816 – 287). I ignored denominators as they are similar between groups.



隔離戴FULL GEAR既是否鬼..
派裝備那位是否係鬼...
派八達通,禮卷那個人是否又係鬼..
TELEGRAM內又有多少係鬼..
朋友被捉,會唔會篤灰,
戴口罩可能係鬼..唔戴又怕被人起底..

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全世界所有目光都集中在了輝瑞新冠疫苗優異的保護率上:參與臨床試驗的志願者一共報告了170例經實驗室PCR檢驗確診的Covid-19病例,疫苗組和安慰劑組分別為8和162例。但病例定義中的疑似Covid-19病例(suspected cases),就是那些有Covid-19病毒感染症狀但未經實驗室PCR確診的病人,佔比太高,這使得所謂「高保護率」有些大打折扣。根據美國食品藥品監督局(FDA)關於輝瑞疫苗的報告,「在全部研究的志願者中,總共有3410例疑似Covid-19病例而未確診,疫苗組發生1594例,安慰劑組發生1816例。」

文章認為:「疑似病例是確診病例的20倍難以置信,疑似病例這一類病人不能簡單地被實驗室PCR檢測為陰性而不算作病人。對疫苗保護率的一個簡單估計是:無論PCR檢測與否,凡是有症狀的都應計算為病人,這樣的話其保護率則為19%,遠遠低於美國藥監局設定的最低保護率為50%的達標門檻。再進一步細分,去掉疫苗接種後7天內發生的病例(輝瑞的接種疫苗組409人,安慰劑組287人,這部分人由於疫苗尚未發揮作用以及接種疫苗副反應可以引起類似的副反應導致),其疫苗保護率才為29%。」
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1)  個 "作者" 即係認為疑似病例而 PCR又未能確診都要當確診? 即係現時如果香港市民有症狀,去做 PCR test, 交回樣本後,結果係陰性都要當確診?

2)  「無論PCR檢測與否,凡是有症狀的都應計算為病人」,唔係呱,我有冇睇錯!我今朝有啲喉嚨痛,行得快有少少氣促,當唔當係病人?


3)  「去掉疫苗接種後7天內發生的病例(輝瑞的接種疫苗組409人,安慰劑組287人,這部分人由於疫苗尚未發揮作用以及接種疫苗副反應可以引起類似的副反應導致),其疫苗保護率才為」29%。」然則作者唔認為應該去掉?

忽然諗開美國登月陰謀論。算把啦!國產疫苗係掂就掂,唔掂就攪乜都冇用,何必枉作小人?

[ 本帖最後由 hfceddie 於 2021-1-12 03:34 PM 編輯 ]



引用:
原帖由 hfceddie 於 2021-1-12 02:48 PM 發表


https://cdn.hk01.com/di/media/images/dw/20210112/425635419762200576602384.jpeg/oREDrpwjtco4R9H9POjcDUfYb7eEy72HwtT-isLU_oo

巴西有媒體報道,中國科興生物研發的新型冠狀病毒(SARS-CoV-2)疫苗,有效率不足60%,雖超過世衛的50%標準,但低於早前傳出近80%有效率。
...
睇嘢不可只睇表面
要睇就是其他國家的反應和態度
如.....天天把民主放在口上,但實際係唔係民主呢?



[隱藏]
引用:
原帖由 hfceddie 於 2021-1-12 03:12 PM 發表

全世界所有目光都集中在了輝瑞新冠疫苗優異的保護率上:參與臨床試驗的志願者一共報告了170例經實驗室PCR檢驗確診的Covid-19病例,疫苗組和安慰劑組分別為8和162例。但病例定義中的疑似Covid-19病例(suspected cases),就是那些有Covid-19病毒感染症狀但未經實驗室PCR確診的病人,佔比太高,這使得所謂「高保護率」有些大打折扣。根據美國食品藥品監督局(FDA)關於輝瑞 ...
#11,#12 有英文原文..

the British Medical Journal

https://www.bmj.com/about-bmj


BMJ started out 180 years ago as a medical journal, publishing articles on stillborn children, amputation at the shoulder and the climate of the Isle of Wight.                Now, as a values-driven company and global brand, we work toward our vision for 'a healthier world.' We do this by partnering with more than 8,000 medical organisations worldwide so they can provide their users with the best available resources.  We make our content available in 14 languages, and create evidence-based subscription-based products to help clinicians better tackle today’s most critical healthcare challenges. It is inspiring to see the rapid growth of students and qualified doctors around the globe progressing their careers and achieving accreditation with our e-learning modules and events.  
Our expertise extends from publishing and medical education to clinical decision support and events to enhance day to day decision-making and healthcare delivery.  Whilst our focus remains unchanged, we continuously adapt to the changing research landscape by remaining innovative and competitive.

BMJ is a global healthcare knowledge provider with a vision for a healthier world. We share knowledge and expertise to improve healthcare outcomes.
We publish more than 70 medical and allied science journals.  Nearly half of our indexed journals rank within the top 10 of their category.

We are well renowned for publishing The BMJ (mostly referred to as the British Medical Journal) - one of the world’s top four most cited general medical journals with a 27.604 impact factor. (Impact Factors are used to measure the importance of a journal by calculating the number of times selected articles are cited within the last few years. The higher the impact factor, the more highly ranked the journal. It is one tool you can use to compare journals in a subject category.)



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