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Specificity of http://www.mjc-palente.fr/buy-cialis-with-free-samples/ erectile dysfunction Antibody Assays Both assays measuring pan-Ig antibodies had cheap cialis canada low numbers of false positives among samples collected in 2017. There were 0 and 1 false positives for the two assays among 472 samples, results that compared favorably with those obtained with the single IgM anti-N and cheap cialis canada IgG anti-N assays (Table S3). Because of the low prevalence of erectile dysfunction in Iceland, we required positive results from both pan-Ig antibody assays for a sample to be considered seropositive (see Supplementary Methods in Supplementary Appendix 1). None of the samples collected in early 2020 group were seropositive, which indicates that the cialis had cheap cialis canada not spread widely in Iceland before February 2020.

erectile dysfunction Antibodies among qPCR-Positive Persons Figure 2. Figure 2 cheap cialis canada. Antibody Prevalence and Titers among qPCR-Positive Cases as a Function of Time since Diagnosis by qPCR. Shown are the percentages of samples positive for both pan-Ig antibody assays and the antibody cheap cialis canada titers.

Red denotes the count or percentage of samples among persons during their hospitalization (249 samples from 48 persons), and blue denotes the count or percentage of samples among persons after they were declared recovered (1853 samples from 1215 persons). Vertical bars cheap cialis canada denote 95% confidence intervals. The dashed lines indicated the thresholds for a test to be declared positive. OD denotes cheap cialis canada optical density, and RBD receptor binding domain.Table 1.

Table 1. Prevalence of erectile dysfunction Antibodies by Sample Collection as Measured by Two Pan-Ig cheap cialis canada Antibody Assays. Twenty-five days after diagnosis by qPCR, more than 90% of samples from recovered persons tested positive with both pan-Ig antibody assays, and the percentage of persons testing positive remained stable thereafter cheap cialis canada (Figure 2 and Fig. S2).

Hospitalized persons seroconverted more frequently and quickly after qPCR diagnosis than did cheap cialis canada nonhospitalized persons (Figure 2 and Fig. S3). Of 1215 persons who cheap cialis canada had recovered (on the basis of results for the most recently obtained sample from persons for whom we had multiple samples), 1107 were seropositive (91.1%. 95% confidence interval [CI], 89.4 to 92.6) (Table 1 and Table S4).

Since some diagnoses may have been made on the basis of false positive qPCR results, we determined that 91.1% represents the lower bound of sensitivity of the combined pan-Ig tests for the detection of cheap cialis canada erectile dysfunction antibodies among recovered persons. Table 2. Table 2 cheap cialis canada. Results of Repeated Pan-Ig Antibody Tests among Recovered qPCR-Diagnosed Persons.

Among the 487 recovered persons with two or more samples, 19 (4%) had different pan-Ig antibody test results at different time points cheap cialis canada (Table 2 and Fig. S4). It is notable that of the 22 persons with an early sample that tested negative for both pan-Ig antibodies, 19 remained negative cheap cialis canada at the most recent test date (again, for both antibodies). One person tested positive for both pan-Ig antibodies in the first test and negative for both in the most recent test.

The longitudinal changes in antibody levels among recovered persons were consistent with the cheap cialis canada cross-sectional results (Fig. S5). Antibody levels were higher in the last sample than in the first sample when the antibodies were measured with the two pan-Ig assays, slightly lower than in the first sample when measured with IgG anti-N and IgG anti-S1 assays, and substantially lower than in the first sample when measured with IgM anti-N and IgA anti-S1 assays. IgG anti-N, IgM anti-N, IgG anti-S1, and IgA anti-S1 antibody levels were correlated among the qPCR-positive persons (Figs.

S5 and S6 and Table S5). Antibody levels measured with both pan-Ig antibody assays increased over the first 2 months after qPCR diagnosis and remained at a plateau over the next 2 months of the study. IgM anti-N antibody levels increased rapidly soon after diagnosis and then fell rapidly and were generally not detected after 2 months. IgA anti-S1 antibodies decreased 1 month after diagnosis and remained detectable thereafter.

IgG anti-N and anti-S1 antibody levels increased during the first 6 weeks after diagnosis and then decreased slightly. erectile dysfunction in Quarantine Table 3. Table 3. erectile dysfunction among Quarantined Persons According to Exposure Type and Presence of Symptoms.

Of the 1797 qPCR-positive Icelanders, 1088 (61%) were in quarantine when erectile dysfunction was diagnosed by qPCR. We tested for antibodies among 4222 quarantined persons who had not tested qPCR-positive (they had received a negative result by qPCR or had simply not been tested). Of those 4222 quarantined persons, 97 (2.3%. 95% CI, 1.9 to 2.8) were seropositive (Table 1).

Those with household exposure were 5.2 (95% CI, 3.3 to 8.0) times more likely to be seropositive than those with other types of exposure (Table 3). Similarly, a positive result by qPCR for those with household exposure was 5.2 (95% CI, 4.5 to 6.1) times more likely than for those with other types of exposure. When these two sets of results (qPCR-positive and seropositive) were combined, we calculated that 26.6% of quarantined persons with household exposure and 5.0% of quarantined persons without household exposure were infected. Those who had symptoms during quarantine were 3.2 (95% CI, 1.7 to 6.2) times more likely to be seropositive and 18.2 times (95% CI, 14.8 to 22.4) more likely to test positive with qPCR than those without symptoms.

We also tested persons in two regions of Iceland affected by cluster outbreaks. In a erectile dysfunction cluster in Vestfirdir, 1.4% of residents were qPCR-positive and 10% of residents were quarantined. We found that none of the 326 persons outside quarantine who had not been tested by qPCR (or who tested negative) were seropositive. In a cluster in Vestmannaeyjar, 2.3% of residents were qPCR-positive and 13% of residents were quarantined.

Of the 447 quarantined persons who had not received a qPCR-positive result, 4 were seropositive (0.9%. 95% CI, 0.3 to 2.1). Of the 663 outside quarantine in Vestmannaeyjar, 3 were seropositive (0.5%. 95% CI, 0.1 to 0.2%).

erectile dysfunction Seroprevalence in Iceland None of the serum samples collected from 470 healthy Icelanders between February 18 and March 9, 2020, tested positive for both pan-Ig antibodies, although four were positive for the pan-Ig anti-N assay (0.9%), a finding that suggests that the cialis had not spread widely in Iceland before March 9. Of the 18,609 persons tested for erectile dysfunction antibodies through contact with the Icelandic health care system for reasons other than erectile dysfunction treatment, 39 were positive for both pan-Ig antibody assays (estimated seroprevalence by weighting the sample on the basis of residence, sex, and 10-year age category, 0.3%. 95% CI, 0.2 to 0.4). There were regional differences in the percentages of qPCR-positive persons across Iceland that were roughly proportional to the percentage of people quarantined (Table S6).

However, after exclusion of the qPCR-positive and quarantined persons, the percentage of persons who tested positive for erectile dysfunction antibodies did not correlate with the percentage of those who tested positive by qPCR. The estimated seroprevalence in the random sample collection from Reykjavik (0.4%. 95% CI, 0.3 to 0.6) was similar to that in the Health Care group (0.3%. 95% CI, 0.2 to 0.4) (Table S6).

We calculate that 0.5% of the residents of Iceland have tested positive with qPCR. The 2.3% with erectile dysfunction seroconversion among persons in quarantine extrapolates to 0.1% of Icelandic residents. On the basis of this finding and the seroprevalence from the Health Care group, we estimate that 0.9% (95% CI, 0.8 to 0.9) of the population of Iceland has been infected by erectile dysfunction. Approximately 56% of all erectile dysfunction s were therefore diagnosed by qPCR, 14% occurred in quarantine without having been diagnosed with qPCR, and the remaining 30% of s occurred outside quarantine and were not detected by qPCR.

Deaths from erectile dysfunction treatment in Iceland In Iceland, 10 deaths have been attributed to erectile dysfunction treatment, which corresponds to 3 deaths per 100,000 nationwide. Among the qPCR-positive cases, 0.6% (95% CI, 0.3 to 1.0) were fatal. Using the 0.9% prevalence of erectile dysfunction in Iceland as the denominator, however, we calculate an fatality risk of 0.3% (95% CI, 0.2 to 0.6). Stratified by age, the fatality risk was substantially lower in those 70 years old or younger (0.1%.

95% CI, 0.0 to 0.3) than in those over 70 years of age (4.4%. 95% CI, 1.9 to 8.4) (Table S7). Age, Sex, Clinical Characteristics, and Antibody Levels Table 4. Table 4.

Association of Existing Conditions and erectile dysfunction treatment Severity with erectile dysfunction Antibody Levels among Recovered Persons. erectile dysfunction antibody levels were higher in older people and in those who were hospitalized (Table 4, and Table S8 [described in Supplementary Appendix 1 and available in Supplementary Appendix 2]). Pan-Ig anti–S1-RBD and IgA anti-S1 levels were lower in female persons. Of the preexisting conditions, and after adjustment for multiple testing, we found that body-mass index, smoking status, and use of antiinflammatory medication were associated with erectile dysfunction antibody levels.

Body-mass index correlated positively with antibody levels. Smokers and users of antiinflammatory medication had lower antibody levels. With respect to clinical characteristics, antibody levels were most strongly associated with hospitalization and clinical severity, followed by clinical symptoms such as fever, maximum temperature reading, cough, and loss of appetite. Severity of these individual symptoms, with the exception of loss of energy, was associated with higher antibody levels.To the Editor.

Rapid and accurate diagnostic tests are essential for controlling the ongoing erectile dysfunction treatment cialis. Although the current standard involves testing of nasopharyngeal swab specimens by quantitative reverse-transcriptase polymerase chain reaction (RT-qPCR) to detect erectile dysfunction, saliva specimens may be an alternative diagnostic sample.1-4 Rigorous evaluation is needed to determine how saliva specimens compare with nasopharyngeal swab specimens with respect to sensitivity in detection of erectile dysfunction during the course of . A total of 70 inpatients with erectile dysfunction treatment provided written informed consent to participate in our study (see the Methods section in Supplementary Appendix 1, available with the full text of this letter at NEJM.org). After erectile dysfunction treatment was confirmed with a positive nasopharyngeal swab specimen at hospital admission, we obtained additional samples from the patients during hospitalization.

We tested saliva specimens collected by the patients themselves and nasopharyngeal swabs collected from the patients at the same time point by health care workers. Figure 1. Figure 1. erectile dysfunction RNA Titers in Saliva Specimens and Nasopharyngeal Swab Specimens.

Samples were obtained from 70 hospital inpatients who had a diagnosis of erectile dysfunction treatment. Panel A shows erectile dysfunction RNA titers in the first available nasopharyngeal and saliva samples. The lines indicate samples from the same patient. Results were compared with the use of a Wilcoxon signed-rank test (P<0.001).

Panel B shows percentages of positivity for erectile dysfunction in tests of the first matched nasopharyngeal and saliva samples at 1 to 5 days, 6 to 10 days, and 11 or more days (maximum, 53 days) after the diagnosis of erectile dysfunction treatment. Panel C shows longitudinal erectile dysfunction RNA copies per milliliter in 97 saliva samples, according to days since symptom onset. Each circle represents a separate sample. Dashed lines indicate additional samples from the same patient.

The red line indicates a negative saliva sample that was followed by a positive sample at the next collection of a specimen. Panel D shows longitudinal erectile dysfunction RNA copies per milliliter in 97 nasopharyngeal swab specimens, according to days since symptom onset. The red lines indicate negative nasopharyngeal swab specimens there were followed by a positive swab at the next collection of a specimen. The gray area in Panels C and D indicates samples that were below the lower limit of detection of 5610 cialis RNA copies per milliliter of sample, which is at cycle threshold 38 of our quantitative reverse-transcriptase polymerase chain reaction assay targeting the erectile dysfunction N1 sequence recommended by the Centers for Disease Control and Prevention.

To analyze these data, we used a linear mixed-effects regression model (see Supplementary Appendix 1) that accounts for the correlation between samples collected from the same person at a single time point (i.e., multivariate response) and the correlation between samples collected across time from the same patient (i.e., repeated measures). All the data used to generate this figure, including the raw cycle thresholds, are provided in Supplementary Data 1 in Supplementary Appendix 2.Using primer sequences from the Centers for Disease Control and Prevention, we detected more erectile dysfunction RNA copies in the saliva specimens (mean log copies per milliliter, 5.58. 95% confidence interval [CI], 5.09 to 6.07) than in the nasopharyngeal swab specimens (mean log copies per milliliter, 4.93. 95% CI, 4.53 to 5.33) (Figure 1A, and Fig.

S1 in Supplementary Appendix 1). In addition, a higher percentage of saliva samples than nasopharyngeal swab samples were positive up to 10 days after the erectile dysfunction treatment diagnosis (Figure 1B). At 1 to 5 days after diagnosis, 81% (95% CI, 71 to 96) of the saliva samples were positive, as compared with 71% (95% CI, 67 to 94) of the nasopharyngeal swab specimens. These findings suggest that saliva specimens and nasopharyngeal swab specimens have at least similar sensitivity in the detection of erectile dysfunction during the course of hospitalization.

Because the results of testing of nasopharyngeal swab specimens to detect erectile dysfunction may vary with repeated sampling in individual patients,5 we evaluated viral detection in matched samples over time. The level of erectile dysfunction RNA decreased after symptom onset in both saliva specimens (estimated slope, −0.11. 95% credible interval, −0.15 to −0.06) (Figure 1C) and nasopharyngeal swab specimens (estimated slope, −0.09. 95% credible interval, −0.13 to −0.05) (Figure 1D).

In three instances, a negative nasopharyngeal swab specimen was followed by a positive swab at the next collection of a specimen (Figure 1D). This phenomenon occurred only once with the saliva specimens (Figure 1C). During the clinical course, we observed less variation in levels of erectile dysfunction RNA in the saliva specimens (standard deviation, 0.98 cialis RNA copies per milliliter. 95% credible interval, 0.08 to 1.98) than in the nasopharyngeal swab specimens (standard deviation, 2.01 cialis RNA copies per milliliter.

95% credible interval, 1.29 to 2.70) (see Supplementary Appendix 1). Recent studies have shown that erectile dysfunction can be detected in the saliva of asymptomatic persons and outpatients.1-3 We therefore screened 495 asymptomatic health care workers who provided written informed consent to participate in our prospective study, and we used RT-qPCR to test both saliva and nasopharyngeal samples obtained from these persons. We detected erectile dysfunction RNA in saliva specimens obtained from 13 persons who did not report any symptoms at or before the time of sample collection. Of these 13 health care workers, 9 had collected matched nasopharyngeal swab specimens by themselves on the same day, and 7 of these specimens tested negative (Fig.

S2). The diagnosis in the 13 health care workers with positive saliva specimens was later confirmed in diagnostic testing of additional nasopharyngeal samples by a CLIA (Clinical Laboratory Improvement Amendments of 1988)–certified laboratory. Variation in nasopharyngeal sampling may be an explanation for false negative results, so monitoring an internal control for proper sample collection may provide an alternative evaluation technique. In specimens collected from inpatients by health care workers, we found greater variation in human RNase P cycle threshold (Ct) values in nasopharyngeal swab specimens (standard deviation, 2.89 Ct.

95% CI, 26.53 to 27.69) than in saliva specimens (standard deviation, 2.49 Ct. 95% CI, 23.35 to 24.35). When health care workers collected their own specimens, we also found greater variation in RNase P Ct values in nasopharyngeal swab specimens (standard deviation, 2.26 Ct. 95% CI, 28.39 to 28.56) than in saliva specimens (standard deviation , 1.65 Ct.

95% CI, 24.14 to 24.26) (Fig. S3). Collection of saliva samples by patients themselves negates the need for direct interaction between health care workers and patients. This interaction is a source of major testing bottlenecks and presents a risk of nosocomial .

Collection of saliva samples by patients themselves also alleviates demands for supplies of swabs and personal protective equipment. Given the growing need for testing, our findings provide support for the potential of saliva specimens in the diagnosis of erectile dysfunction . Anne L. Wyllie, Ph.D.Yale School of Public Health, New Haven, CT [email protected]John Fournier, M.D.Yale School of Medicine, New Haven, CTArnau Casanovas-Massana, Ph.D.Yale School of Public Health, New Haven, CTMelissa Campbell, M.D.Maria Tokuyama, Ph.D.Pavithra Vijayakumar, B.A.Yale School of Medicine, New Haven, CTJoshua L.

Warren, Ph.D.Yale School of Public Health, New Haven, CTBertie Geng, M.D.Yale School of Medicine, New Haven, CTM. Catherine Muenker, M.S.Adam J. Moore, M.P.H.Chantal B.F. Vogels, Ph.D.Mary E.

Petrone, B.S.Isabel M. Ott, B.S.Yale School of Public Health, New Haven, CTPeiwen Lu, Ph.D.Arvind Venkataraman, B.S.Alice Lu-Culligan, B.S.Jonathan Klein, B.S.Yale School of Medicine, New Haven, CTRebecca Earnest, M.P.H.Yale School of Public Health, New Haven, CTMichael Simonov, M.D.Rupak Datta, M.D., Ph.D.Ryan Handoko, M.D.Nida Naushad, B.S.Lorenzo R. Sewanan, M.Phil.Jordan Valdez, B.S.Yale School of Medicine, New Haven, CTElizabeth B. White, A.B.Sarah Lapidus, M.S.Chaney C.

Kalinich, M.P.H.Yale School of Public Health, New Haven, CTXiaodong Jiang, M.D., Ph.D.Daniel J. Kim, A.B.Eriko Kudo, Ph.D.Melissa Linehan, M.S.Tianyang Mao, B.S.Miyu Moriyama, Ph.D.Ji E. Oh, M.D., Ph.D.Annsea Park, B.A.Julio Silva, B.S.Eric Song, M.S.Takehiro Takahashi, M.D., Ph.D.Manabu Taura, Ph.D.Orr-El Weizman, B.A.Patrick Wong, M.S.Yexin Yang, B.S.Santos Bermejo, B.S.Yale School of Medicine, New Haven, CTCamila D. Odio, M.D.Yale New Haven Health, New Haven, CTSaad B.

Omer, M.B., B.S., Ph.D.Yale Institute for Global Health, New Haven, CTCharles S. Dela Cruz, M.D., Ph.D.Shelli Farhadian, M.D., Ph.D.Richard A. Martinello, M.D.Akiko Iwasaki, Ph.D.Yale School of Medicine, New Haven, CTNathan D. Grubaugh, Ph.D.Albert I.

Ko, M.D.Yale School of Public Health, New Haven, CT [email protected], [email protected] Supported by the Huffman Family Donor Advised Fund, a Fast Grant from Emergent Ventures at the Mercatus Center at George Mason University, the Yale Institute for Global Health, the Yale School of Medicine, a grant (U19 AI08992, to Dr. Ko) from the National Institute of Allergy and Infectious Diseases, the Beatrice Kleinberg Neuwirth Fund, and a grant (Rubicon 019.181EN.004, to Dr. Vogel) from the Dutch Research Council (NWO). Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org.

This letter was published on August 28, 2020, at NEJM.org. Drs. Grubaugh and Ko contributed equally to this letter. 5 References1.

Kojima N, Turner F, Slepnev V, et al. Self-collected oral fluid and nasal swabs demonstrate comparable sensitivity to clinician collected nasopharyngeal swabs for erectile dysfunction treatment detection. April 15, 2020 (https://www.medrxiv.org/content/10.1101/2020.04.11.20062372v1). Preprint.Google Scholar2.

Williams E, Bond K, Zhang B, Putland M, Williamson DA. Saliva as a non-invasive specimen for detection of erectile dysfunction. J Clin Microbiol 2020;58(8):e00776-20-e00776-20.3. Pasomsub E, Watcharananan SP, Boonyawat K, et al.

Saliva sample as a non-invasive specimen for the diagnosis of erectile dysfunction disease 2019. A cross-sectional study. Clin Microbiol Infect 2020 May 15 (Epub ahead of print).4. Vogels CBF, Brackney D, Wang J, et al.

SalivaDirect. Simple and sensitive molecular diagnostic test for erectile dysfunction surveillance. August 4, 2020 (https://www.medrxiv.org/content/10.1101/2020.08.03.20167791v1). Preprint.Google Scholar5.

Zou L, Ruan F, Huang M, et al. erectile dysfunction viral load in upper respiratory specimens of infected patients. N Engl J Med 2020;382:1177-1179.Trial Population Table 1. Table 1.

Demographic Characteristics of the Participants in the NVX-CoV2373 Trial at Enrollment. The trial was initiated on May 26, 2020. 134 participants underwent randomization between May 27 and June 6, 2020, including 3 participants who were to serve as backups for sentinel dosing and who immediately withdrew from the trial without being vaccinated (Fig. S1).

Of the 131 participants who received injections, 23 received placebo (group A), 25 received 25-μg doses of rerectile dysfunction (group B), 29 received 5-μg doses of rerectile dysfunction plus Matrix-M1, including three sentinels (group C), 28 received 25-μg doses of rerectile dysfunction plus Matrix-M1, including three sentinels (group D), and 26 received a single 25-μg dose of rerectile dysfunction plus Matrix-M1 followed by a single dose of placebo (group E). All 131 participants received their first vaccination on day 0, and all but 3 received their second vaccination at least 21 days later. Exceptions include 2 in the placebo group (group A) who withdrew consent (unrelated to any adverse event) and 1 in the 25-μg rerectile dysfunction + Matrix-M1 group (group D) who had an unsolicited adverse event (mild cellulitis. See below).

Demographic characteristics of the participants are presented in Table 1. Of note, missing data were infrequent. Safety Outcomes No serious adverse events or adverse events of special interest were reported, and vaccination pause rules were not implemented. As noted above, one participant did not receive a second vaccination owing to an unsolicited adverse event, mild cellulitis, that was associated with after an intravenous cannula placement to address an unrelated mild adverse event that occurred during the second week of follow-up.

Second vaccination was withheld because the participant was still recovering and receiving antibiotics. This participant remains in the trial. Figure 2. Figure 2.

Solicited Local and Systemic Adverse Events. The percentage of participants in each treatment group (groups A, B, C, D, and E) with adverse events according to the maximum FDA toxicity grade (mild, moderate, or severe) during the 7 days after each vaccination is plotted for solicited local (Panel A) and systemic (Panel B) adverse events. There were no grade 4 (life-threatening) events. Participants who reported 0 events make up the remainder of the 100% calculation (not displayed).

Excluded were the three sentinel participants in groups C (5 μg + Matrix-M1, 5 μg + Matrix-M1) and D (25 μg + Matrix-M1, 25 μg + Matrix-M1), who received the trial treatment in an open-label manner (see Table S7 for complete safety data on all participants).Overall reactogenicity was largely absent or mild, and second vaccinations were neither withheld nor delayed due to reactogenicity. After the first vaccination, local and systemic reactogenicity was absent or mild in the majority of participants (local. 100%, 96%, 89%, 84%, and 88% of participants in groups A, B, C, D, and E, respectively. Systemic.

91%, 92%, 96%, 68%, and 89%) who were unaware of treatment assignment (Figure 2 and Table S7). Two participants (2%), one each in groups D and E, had severe adverse events (headache, fatigue, and malaise). Two participants, one each in groups A and E, had reactogenicity events (fatigue, malaise, and tenderness) that extended 2 days after day 7. After the second vaccination, local and systemic reactogenicity were absent or mild in the majority of participants in the five groups (local.

100%, 100%, 65%, 67%, and 100% of participants, respectively. Systemic. 86%, 84%, 73%, 58%, and 96%) who were unaware of treatment assignment. One participant, in group D, had a severe local event (tenderness), and eight participants, one or two participants in each group, had severe systemic events.

The most common severe systemic events were joint pain and fatigue. Only one participant, in group D, had fever (temperature, 38.1°C) after the second vaccination, on day 1 only. No adverse event extended beyond 7 days after the second vaccination. Of note, the mean duration of reactogenicity events was 2 days or less for both the first vaccination and second vaccination periods.

Laboratory abnormalities of grade 2 or higher occurred in 13 participants (10%). 9 after the first vaccination and 4 after the second vaccination (Table S8). Abnormal laboratory values were not associated with any clinical manifestations and showed no worsening with repeat vaccination. Six participants (5%.

Five women and one man) had grade 2 or higher transient reductions in hemoglobin from baseline, with no evidence of hemolysis or microcytic anemia and with resolution within 7 to 21 days. Of the six, two had an absolute hemoglobin value (grade 2) that resolved or stabilized during the testing period. Four participants (3%), including one who had received placebo, had elevated liver enzymes that were noted after the first vaccination and resolved within 7 to 14 days (i.e., before the second vaccination). Vital signs remained stable immediately after vaccination and at all visits.

Unsolicited adverse events (Table S9) were predominantly mild in severity (in 71%, 91%, 83%, 90%, and 82% of participants in groups A, B, C, D, and E, respectively) and were similarly distributed across the groups receiving adjuvanted and unadjuvanted treatment. There were no reports of severe adverse events. Immunogenicity Outcomes Figure 3. Figure 3.

erectile dysfunction Anti-Spike IgG and Neutralizing Antibody Responses. Shown are geometric mean anti-spike IgG enzyme-linked immunosorbent assay (ELISA) unit responses to recombinant severe acute respiratory syndrome erectile dysfunction 2 (rerectile dysfunction) protein antigens (Panel A) and wild-type erectile dysfunction microneutralization assay at an inhibitory concentration greater than 99% (MN IC>99%) titer responses (Panel B) at baseline (day 0), 3 weeks after the first vaccination (day 21), and 2 weeks after the second vaccination (day 35) for the placebo group (group A), the 25-μg unadjuvanted group (group B), the 5-μg and 25-μg adjuvanted groups (groups C and D, respectively), and the 25-μg adjuvanted and placebo group (group E). Diamonds and whisker endpoints represent geometric mean titer values and 95% confidence intervals, respectively. The erectile dysfunction treatment human convalescent serum panel includes specimens from PCR-confirmed erectile dysfunction treatment participants, obtained from Baylor College of Medicine (29 specimens for ELISA and 32 specimens for MN IC>99%), with geometric mean titer values according to erectile dysfunction treatment severity.

The severity of erectile dysfunction treatment is indicated by the colors of the dots for hospitalized patients (including those in intensive care), symptomatic outpatients (with samples collected in the emergency department), and asymptomatic patients who had been exposed to erectile dysfunction treatment (with samples collected during contact and exposure assessment). Mean values (in black) for human convalescent serum are depicted next to (and of same color as) the category of erectile dysfunction treatment patients, with the overall mean shown above the scatter plot (in black). For each trial treatment group, the mean at day 35 is depicted above the scatterplot.ELISA anti-spike IgG geometric mean ELISA units (GMEUs) ranged from 105 to 116 at day 0. By day 21, responses had occurred for all adjuvanted regimens (1984, 2626, and 3317 GMEUs for groups C, D, and E, respectively), and geometric mean fold rises (GMFRs) exceeded those induced without adjuvant by a factor of at least 10 (Figure 3 and Table S10).

Within 7 days after the second vaccination with adjuvant (day 28. Groups C and D), GMEUs had further increased by a factor of 8 (to 15,319 and 20,429, respectively) over responses seen with the first vaccination, and within 14 days (day 35), responses had more than doubled yet again (to 63,160 and 47,521, respectively), achieving GMFRs that were approximately 100 times greater than those observed with rerectile dysfunction alone. A single vaccination with adjuvant achieved GMEU levels similar to those in asymptomatic (exposed) patients with erectile dysfunction treatment (1661), and a second vaccination with adjuvant achieved GMEU levels that exceeded those in convalescent serum from symptomatic outpatients with erectile dysfunction treatment (7420) by a factor of at least 6 and rose to levels similar to those in convalescent serum from patients hospitalized with erectile dysfunction treatment (53,391). The responses in the two-dose 5-μg and 25-μg adjuvanted treatment regimens were similar, a finding that highlights the role of adjuvant dose sparing.

Neutralizing antibodies were undetectable before vaccination and had patterns of response similar to those of anti-spike antibodies after vaccination with adjuvant (Figure 3 and Table S11). After the first vaccination (day 21), GMFRs were approximately 5 times greater with adjuvant (5.2, 6.3, and 5.9 for groups C, D, and E, respectively) than without adjuvant (1.1). By day 35, second vaccinations with adjuvant induced an increase more than 100 times greater (195 and 165 for groups C and D, respectively) than single vaccinations without adjuvant. When compared with convalescent serum, second vaccinations with adjuvant resulted in GMT levels approximately 4 times greater (3906 and 3305 for groups C and D, respectively) than those in symptomatic outpatients with erectile dysfunction treatment (837) and approached the magnitude of levels observed in hospitalized patients with erectile dysfunction treatment (7457).

At day 35, ELISA anti-spike IgG GMEUs and neutralizing antibodies induced by the two-dose 5-μg and 25-μg adjuvanted treatment regimens were 4 to 6 times greater than the geometric mean convalescent serum measures (8344 and 983, respectively). Figure 4. Figure 4. Correlation of Anti-Spike IgG and Neutralizing Antibody Responses.

Shown are scatter plots of 100% wild-type neutralizing antibody responses and anti-spike IgG ELISA unit responses at 3 weeks after the first vaccination (day 21) and 2 weeks after the second vaccination (day 35) for the two-dose 25-μg unadjuvanted treatment (group B. Panel A), the combined two-dose 5-μg and 25-μg adjuvanted treatment (groups C and D, respectively. Panel B), and convalescent serum from patients with erectile dysfunction treatment (Panel C). In Panel C, the severity of erectile dysfunction treatment is indicated by the colors of the dots for hospitalized patients (including those in intensive care), symptomatic outpatients (with samples collected in the emergency department), and asymptomatic patients who had been exposed to erectile dysfunction treatment (with samples collected during contact and exposure assessment).A strong correlation was observed between neutralizing antibody titers and anti-spike IgG GMEUs with adjuvanted treatment at day 35 (correlation, 0.95) (Figure 4), a finding that was not observed with unadjuvanted treatment (correlation, 0.76) but was similar to that of convalescent serum (correlation, 0.96).

Two-dose regimens of 5-μg and 25-μg rerectile dysfunction plus Matrix-M1 produced similar magnitudes of response, and every participant had seroconversion according to either assay measurement. Reverse cumulative-distribution curves for day 35 are presented in Figure S2. Figure 5. Figure 5.

Rerectile dysfunction CD4+ T-cell Responses with or without Matrix-M1 Adjuvant. Frequencies of antigen-specific CD4+ T cells producing T helper 1 (Th1) cytokines interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), and interleukin-2 and for T helper 2 (Th2) cytokines interleukin-5 and interleukin-13 indicated cytokines from four participants each in the placebo (group A), 25-μg unadjuvanted (group B), 5-μg adjuvanted (group C), and 25-μg adjuvanted (group D) groups at baseline (day 0) and 1 week after the second vaccination (day 28) after stimulation with the recombinant spike protein. €œAny 2Th1” indicates CD4+ T cells that can produce two types of Th1 cytokines at the same time. €œAll 3 Th1” indicates CD4+ T cells that produce IFN-γ, TNF-α, and interleukin-2 simultaneously.

€œBoth Th2” indicates CD4+ T cells that can produce Th2 cytokines interleukin-5 and interleukin-13 at the same time.T-cell responses in 16 participants who were randomly selected from groups A through D, 4 participants per group, showed that adjuvanted regimens induced antigen-specific polyfunctional CD4+ T-cell responses that were reflected in IFN-γ, IL-2, and TNF-α production on spike protein stimulation. A strong bias toward this Th1 phenotype was noted. Th2 responses (as measured by IL-5 and IL-13 cytokines) were minimal (Figure 5).Start Preamble Centers for Medicare &. Medicaid Services (CMS), HHS.

Extension of timeline for publication of final rule. This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule. As of August 26, 2020, the timeline for publication of the final rule to finalize the provisions of the October 17, 2019 proposed rule (84 FR 55766) is extended until August 31, 2021. Start Further Info Lisa O.

Wilson, (410) 786-8852. End Further Info End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule that addressed undue regulatory impact and burden of the physician self-referral law. The proposed rule was issued in conjunction with the Centers for Medicare &. Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care.

In the proposed rule, we proposed exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician. A new exception for donations of cybersecurity technology and related services. And amendments to the existing exception for electronic health records (EHR) items and services.

The proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations. This notice announces an extension of the timeline for publication of the final rule and the continuation of effectiveness of the proposed rule. Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not be longer than 3 years except under exceptional circumstances.

In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification for the variation. We announced in the Spring 2020 Unified Agenda (June 30, 2020, www.reginfo.gov) that we would issue the final rule in August 2020. However, we are still working through the Start Printed Page 52941complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date. This notice extends the timeline for publication of the final rule until August 31, 2021.

Start Signature Dated. August 24, 2020. Wilma M. Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services.

End Signature End Supplemental Information [FR Doc. 2020-18867 Filed 8-26-20. 8:45 am]BILLING CODE 4120-01-PStart Preamble Notice of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures.

This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is effective as of August 24, 2020. Start Further Info Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201. Telephone.

202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2.

It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.

Section 319F-3 of the PHS Act has been amended by the cialis and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the erectile dysfunction Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the erectile dysfunction treatment outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020.

On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020).

On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm erectile dysfunction treatment might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any treatment that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended treatments).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only erectile dysfunction treatment caused by erectile dysfunction or a cialis mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a cialis mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure.

€œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed. Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric treatment ordering and doses administered might indicate that U.S.

Children and their communities face increased risks for outbreaks of treatment-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other erectile dysfunction treatment mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to erectile dysfunction treatment during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the erectile dysfunction treatment cialis. The survey, which was limited to practices participating in the treatments for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed. Most practices had reduced office hours for in-person visits. When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure.

Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here. If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations. Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the erectile dysfunction treatment cialis, including. Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations.

Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms. Adhering to recommended social (physical) distancing and other -control practices, such as the use of masks. The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by erectile dysfunction treatment. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates.

We must quickly do so to avoid preventable s in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of erectile dysfunction treatment. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations. Many States already allow pharmacists to administer treatments to children of any age.[] Other States permit pharmacists to administer treatments to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those treatments.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience. What is more, pharmacists are trusted healthcare professionals with established relationships with their patients.

Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate. For example, pharmacists already play a significant role in annual influenza vaccination. In the early 2018-19 season, they administered the influenza treatment to nearly a third of all adults who received the treatment.[] Given the potential danger of serious influenza and continuing erectile dysfunction treatment outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the erectile dysfunction treatment cialis, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza treatment to children will make vaccinations more accessible.

Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers treatments to individuals ages three through 18 pursuant to the following requirements. The treatment must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.[] The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE.

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer treatments to children and permit licensed or registered pharmacy interns acting under their supervision to administer treatments to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children. That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the treatment.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e. Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended treatments according to ACIP's standard immunization schedule. All States require children to be vaccinated against certain communicable diseases as a condition of school attendance.

These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended treatments and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended treatments ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified cialis and epidemic products that “limit the harm such cialis or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140erectile dysfunction treatment as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration. Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C.

300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures. Section VIII.

Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by erectile dysfunction treatment. The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only erectile dysfunction treatment caused by erectile dysfunction or a cialis mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a cialis mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against erectile dysfunction treatment. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against erectile dysfunction treatment, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below.

All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr. 15, 2020) and 85 FR 35100 (June 8, 2020). 1.

Covered Persons, section V, delete in full and replace with. V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States.

In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency. (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

And (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. The treatment must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule.

The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.

The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.

Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program.

All other Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures. 2. Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. VIII.

Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only erectile dysfunction treatment caused by erectile dysfunction or a cialis mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by erectile dysfunction treatment, erectile dysfunction, or a cialis mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Start Authority 42 U.S.C. 247d-6d.

End Authority Start Signature Dated. August 19, 2020. Alex M. Azar II, Secretary of Health and Human Services.

End Signature End Supplemental Information [FR Doc. 2020-18542 Filed 8-20-20. 4:15 pm]BILLING CODE 4150-03-P.

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The further procedures that one participant check this in the placebo group declined after dose 2 how do i get cialis (lower right corner of the diagram) were those involving collection of blood and nasal swab samples.Table 1. Table 1. Demographic Characteristics of the Participants in the Main Safety Population. Between July 27, 2020, and November 14, 2020, a total of 44,820 persons were screened, and 43,548 persons 16 years of age or older underwent randomization at 152 sites worldwide (United States, 130 sites how do i get cialis.

Argentina, 1. Brazil, 2. South Africa, 4 how do i get cialis. Germany, 6.

And Turkey, 9) in the phase 2/3 portion of the trial. A total of 43,448 participants received how do i get cialis injections. 21,720 received BNT162b2 and 21,728 received placebo (Figure 1). At the data cut-off date of October 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set.

Among these 37,706 participants, 49% were female, 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese (body mass index [the weight in kilograms divided by the square of the height how do i get cialis in meters] of at least 30.0), and 21% had at least one coexisting condition. The median age was 52 years, and 42% of participants were older than 55 years of age (Table 1 and Table S2). Safety Local Reactogenicity Figure 2. Figure 2 how do i get cialis.

Local and Systemic Reactions Reported within 7 Days after Injection of BNT162b2 or Placebo, According to Age Group. Data on local and systemic reactions and use of medication were collected with electronic diaries from participants in the reactogenicity subset (8,183 participants) for 7 days after each vaccination. Solicited injection-site how do i get cialis (local) reactions are shown in Panel A. Pain at the injection site was assessed according to the following scale.

Mild, does not interfere with activity. Moderate, interferes how do i get cialis with activity. Severe, prevents daily activity. And grade 4, emergency department visit or hospitalization.

Redness and swelling were measured according to the following scale how do i get cialis. Mild, 2.0 to 5.0 cm in diameter. Moderate, >5.0 to 10.0 cm in diameter. Severe, >10.0 how do i get cialis cm in diameter.

And grade 4, necrosis or exfoliative dermatitis (for redness) and necrosis (for swelling). Systemic events and medication use are shown in Panel B. Fever categories how do i get cialis are designated in the key. Medication use was not graded.

Additional scales were as follows. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint how do i get cialis pain (mild. Does not interfere with activity. Moderate.

Some interference with how do i get cialis activity. Or severe. Prevents daily activity), vomiting (mild. 1 to how do i get cialis 2 times in 24 hours.

Moderate. >2 times in 24 hours. Or severe how do i get cialis. Requires intravenous hydration), and diarrhea (mild.

2 to 3 loose stools in 24 hours. Moderate. 4 to 5 loose stools in 24 hours. Or severe.

6 or more loose stools in 24 hours). Grade 4 for all events indicated an emergency department visit or hospitalization. Н™¸ bars represent 95% confidence intervals, and numbers above the 𝙸 bars are the percentage of participants who reported the specified reaction.The reactogenicity subset included 8183 participants. Overall, BNT162b2 recipients reported more local reactions than placebo recipients.

Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2). Pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose. 66% after the second dose) than among younger participants (83% after the first dose. 78% after the second dose).

A noticeably lower percentage of participants reported injection-site redness or swelling. The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction. In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Systemic Reactogenicity Systemic events were reported more often by younger treatment recipients (16 to 55 years of age) than by older treatment recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B).

The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger treatment recipients. 51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger treatment recipients. 17% and 14% among older recipients). The frequency of any severe systemic event after the first dose was 0.9% or less.

Severe systemic events were reported in less than 2% of treatment recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose. Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger treatment recipients and by 11% of older recipients. Only 0.2% of treatment recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the treatment and placebo groups reported temperatures above 40.0°C.

Younger treatment recipients were more likely to use antipyretic or pain medication (28% after dose 1. 45% after dose 2) than older treatment recipients (20% after dose 1. 38% after dose 2), and placebo recipients were less likely (10 to 14%) than treatment recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter.

Daily use of the electronic diary ranged from 90 to 93% for each day after the first dose and from 75 to 83% for each day after the second dose. No difference was noted between the BNT162b2 group and the placebo group. Adverse Events Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3). More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%).

This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by treatment recipients than by placebo recipients. Sixty-four treatment recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy. Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial. Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to treatment administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia).

Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the treatment or placebo. No erectile dysfunction treatment–associated deaths were observed. No stopping rules were met during the reporting period.

Safety monitoring will continue for 2 years after administration of the second dose of treatment. Efficacy Table 2. Table 2. treatment Efficacy against erectile dysfunction treatment at Least 7 days after the Second Dose.

Table 3. Table 3. treatment Efficacy Overall and by Subgroup in Participants without Evidence of before 7 Days after Dose 2. Figure 3.

Figure 3. Efficacy of BNT162b2 against erectile dysfunction treatment after the First Dose. Shown is the cumulative incidence of erectile dysfunction treatment after the first dose (modified intention-to-treat population). Each symbol represents erectile dysfunction treatment cases starting on a given day.

Filled symbols represent severe erectile dysfunction treatment cases. Some symbols represent more than one case, owing to overlapping dates. The inset shows the same data on an enlarged y axis, through 21 days. Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point.

The time period for erectile dysfunction treatment case accrual is from the first dose to the end of the surveillance period. The confidence interval (CI) for treatment efficacy (VE) is derived according to the Clopper–Pearson method.Among 36,523 participants who had no evidence of existing or prior erectile dysfunction , 8 cases of erectile dysfunction treatment with onset at least 7 days after the second dose were observed among treatment recipients and 162 among placebo recipients. This case split corresponds to 95.0% treatment efficacy (95% confidence interval [CI], 90.3 to 97.6. Table 2).

Among participants with and those without evidence of prior SARS CoV-2 , 9 cases of erectile dysfunction treatment at least 7 days after the second dose were observed among treatment recipients and 169 among placebo recipients, corresponding to 94.6% treatment efficacy (95% CI, 89.9 to 97.3). Supplemental analyses indicated that treatment efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population (Table 3 and Table S4).

The diagram represents all enrolled http://pupdogs.net/2015/12/20/my-last-gift-to-nina-weena-tofina/ participants cheap cialis canada through November 14, 2020. The safety subset (those with a median of 2 months of follow-up, in accordance with application requirements for Emergency Use Authorization) is based on an October 9, 2020, data cut-off date. The further procedures that one participant in the placebo group declined after dose 2 (lower right corner of the diagram) were those involving collection of blood and nasal swab samples.Table 1. Table 1 cheap cialis canada. Demographic Characteristics of the Participants in the Main Safety Population.

Between July 27, 2020, and November 14, 2020, a total of 44,820 persons were screened, and 43,548 persons 16 years of age or older underwent randomization at 152 sites worldwide (United States, 130 sites. Argentina, 1 cheap cialis canada. Brazil, 2. South Africa, 4. Germany, 6 cheap cialis canada.

And Turkey, 9) in the phase 2/3 portion of the trial. A total of 43,448 participants received injections. 21,720 received BNT162b2 and 21,728 received placebo (Figure 1) cheap cialis canada. At the data cut-off date of October 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set. Among these 37,706 participants, 49% were female, 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese (body mass index [the weight in kilograms divided by the square of the height in meters] of at least 30.0), and 21% had at least one coexisting condition.

The median age was 52 years, and 42% of participants cheap cialis canada were older than 55 years of age (Table 1 and Table S2). Safety Local Reactogenicity Figure 2. Figure 2. Local and Systemic Reactions Reported within 7 Days after Injection of BNT162b2 or Placebo, According to Age Group cheap cialis canada. Data on local and systemic reactions and use of medication were collected with electronic diaries from participants in the reactogenicity subset (8,183 participants) for 7 days after each vaccination.

Solicited injection-site (local) reactions are shown in Panel A. Pain at the injection site was assessed according to the cheap cialis canada following scale. Mild, does not interfere with activity. Moderate, interferes with activity. Severe, prevents cheap cialis canada daily activity.

And grade 4, emergency department visit or hospitalization. Redness and swelling were measured according to the following scale. Mild, 2.0 to 5.0 cm cheap cialis canada in diameter. Moderate, >5.0 to 10.0 cm in diameter. Severe, >10.0 cm in diameter.

And grade cheap cialis canada 4, necrosis or exfoliative dermatitis (for redness) and necrosis (for swelling). Systemic events and medication use are shown in Panel B. Fever categories are designated in the key. Medication use was cheap cialis canada not graded. Additional scales were as follows.

Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain (mild. Does not cheap cialis canada interfere with activity. Moderate. Some interference with activity. Or severe cheap cialis canada.

Prevents daily activity), vomiting (mild. 1 to 2 times in 24 hours. Moderate. >2 times in 24 hours. Or severe.

Requires intravenous hydration), and diarrhea (mild. 2 to 3 loose stools in 24 hours. Moderate. 4 to 5 loose stools in 24 hours. Or severe.

6 or more loose stools in 24 hours). Grade 4 for all events indicated an emergency department visit or hospitalization. Н™¸ bars represent 95% confidence intervals, and numbers above the 𝙸 bars are the percentage of participants who reported the specified reaction.The reactogenicity subset included 8183 participants. Overall, BNT162b2 recipients reported more local reactions than where can you buy cialis over the counter placebo recipients. Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2).

Pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose. 66% after the second dose) than among younger participants (83% after the first dose. 78% after the second dose). A noticeably lower percentage of participants reported injection-site redness or swelling. The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction.

In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Systemic Reactogenicity Systemic events were reported more often by younger treatment recipients (16 to 55 years of age) than by older treatment recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B). The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger treatment recipients. 51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger treatment recipients. 17% and 14% among older recipients).

The frequency of any severe systemic event after the first dose was 0.9% or less. Severe systemic events were reported in less than 2% of treatment recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose. Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger treatment recipients and by 11% of older recipients. Only 0.2% of treatment recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the treatment and placebo groups reported temperatures above 40.0°C.

Younger treatment recipients were more likely to use antipyretic or pain medication (28% after dose 1. 45% after dose 2) than older treatment recipients (20% after dose 1. 38% after dose 2), and placebo recipients were less likely (10 to 14%) than treatment recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter. Daily use of the electronic diary ranged from 90 to 93% for each day after the first dose and from 75 to 83% for each day after the second dose.

No difference was noted between the BNT162b2 group and the placebo group. Adverse Events Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3). More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%). This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by treatment recipients than by placebo recipients. Sixty-four treatment recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy.

Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial. Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to treatment administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia). Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the treatment or placebo. No erectile dysfunction treatment–associated deaths were observed.

No stopping rules were met during the reporting period. Safety monitoring will continue for 2 years after administration of the second dose of treatment. Efficacy Table 2. Table 2. treatment Efficacy against erectile dysfunction treatment at Least 7 days after the Second Dose.

Table 3. Table 3. treatment Efficacy Overall and by Subgroup in Participants without Evidence of before 7 Days after Dose 2. Figure 3. Figure 3.

Efficacy of BNT162b2 against erectile dysfunction treatment after the First Dose. Shown is the cumulative incidence of erectile dysfunction treatment after the first dose (modified intention-to-treat population). Each symbol represents erectile dysfunction treatment cases starting on a given day. Filled symbols represent severe erectile dysfunction treatment cases. Some symbols represent more than one case, owing to overlapping dates.

The inset shows the same data on an enlarged y axis, through 21 days. Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point. The time period for erectile dysfunction treatment case accrual is from the first dose to the end of the surveillance period. The confidence interval (CI) for treatment efficacy (VE) is derived according to the Clopper–Pearson method.Among 36,523 participants who had no evidence of existing or prior erectile dysfunction , 8 cases of erectile dysfunction treatment with onset at least 7 days after the second dose were observed among treatment recipients and 162 among placebo recipients. This case split corresponds to 95.0% treatment efficacy (95% confidence interval [CI], 90.3 to 97.6.

What side effects may I notice from Cialis?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • changes in hearing
  • chest pain
  • fast, irregular heartbeat

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • back pain
  • dizziness
  • flushing
  • headache
  • indigestion
  • muscle aches
  • stuffy or runny nose

This list may not describe all possible side effects.

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A former high school sports standout in the area who went on to play at the collegiate level has died at age 54.Christopher Peter Sennas was cheap cialis canada a 1985 graduate of Nyack High School, where he earned All-County and All-Conference honors in lacrosse.He graduated from Roanoke College in 1989 where he was a four-year member of the men’s lacrosse team and a member of the Sigma Chi Fraternity.He died on Monday, May How to buy cipro online 24, following "a brief and valiant fight with cancer," according to his obituary. He was surrounded by family and friends. Following college, Chris pursued his passion cheap cialis canada for skiing and moved to Utah, joining his lifelong friend and soul sibling, Suzie McDowell, according to his obituary. In Utah, Chris began a 30-year career in plumbing earning a Master Plumber license and becoming a partner in Joe Griffith Plumbing, serving the Park City, Utah community."Chris had a fun-loving spirit that brightened the lives of all who were lucky enough to have known him with a deep devotion to his family and friends," his obituary said. "He found great joy in music, especially the Grateful Dead, and in his beloved dogs, Zeb, Coogan, Boggs, and Chop."He is survived by his mother, Fran.

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My Administration is committed to preventing the tragedy of suicide, ending the best website for generic cialis opioid crisis, and view it now improving mental and behavioral health. Before the erectile dysfunction treatment cialis, these urgent issues were prioritized through significant initiatives, including the President's Roadmap to Empower Veterans and End a National Tragedy of Suicide (PREVENTS), expanded access to medication-assisted treatment and life-saving naloxone, and budget requests for significant investments in the funding of evidence-based treatment for mental- and behavioral-health needs. During the erectile dysfunction treatment cialis, the Federal Government has dedicated billions of dollars and thousands of hours in resources to help Americans, including approximately $425 million in emergency funds to address mental and substance use disorders through the Substance Abuse and Mental Health Services Administration.

The cialis has also exacerbated mental- and behavioral-health conditions as a result of stress from prolonged lockdown orders, lost employment, best website for generic cialis and social isolation. Survey data from the Centers for Disease Control and Prevention show that during the last week of June, 40.9 percent of Americans struggled with mental-health or substance-abuse issues and 10.7 percent reported seriously considering suicide. We must enhance the ability of the Federal Government, as well as its State, local, and Tribal partners, to appropriately address these ongoing mental- and behavioral-health concerns.

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5. Grant Funding for States and best website for generic cialis Organizations that Permit In-Person Treatment and Recovery Support Activities for Mental and Behavioral Health. The heads of agencies, in consultation with the Director of OMB, shall.

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Policy http://www.ec-schluthfeld-strasbourg.ac-strasbourg.fr/wp/?p=816 cheap cialis canada. It is the policy of the United States to prevent suicides, drug-related deaths, and poor behavioral-health outcomes, particularly those that are induced or made worse by prolonged State and local erectile dysfunction treatment shutdown orders. I am therefore issuing a national call to action to.

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The Working Group will be co-chaired by the Secretary of Health and Human Services, or his designee, and the Assistant to the Start Printed Page 63978President for Domestic Policy, or her designee. The Working Group shall be composed of representatives from the Department of Defense, the Department of Justice, the Department of Agriculture, the Department of Labor, the Department of Housing and Urban Development, the Department of Education, the Department of Veterans Affairs, the Small Business Administration, the Office of National Drug Control Policy, the Office of Management and Budget (OMB), and such representatives of other executive departments, agencies, and offices as the Co-Chairs may, from time to time, designate with the concurrence of the head of the department, agency, or office concerned. All members of the Working Group shall be full-time, or permanent part-time, officers or employees of the Federal Government.

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Sec. 5. Grant Funding for States and Organizations that Permit In-Person Treatment and Recovery Support Activities for Mental and Behavioral Health.

The heads of agencies, in consultation with the Director of OMB, shall. (a) Examine their existing grant programs that fund mental-health, medical, or related services and, consistent with applicable law, take steps to encourage grantees to consider adopting policies, where appropriate, that have been shown to improve mental health and reduce suicide risk, including the following. (i) Safe in-person and telehealth participation in support groups for people in recovery from substance use disorders, mental-health issues, or other ailments that benefit from communal support.

And peer-to-peer services that support underserved communities. (ii) Safe face-to-face therapeutic services, including group therapy, to remediate poor behavioral health. And (iii) Safe participation in communal support—both faith-based and secular—including educational programs, civic activities, and in-person religious services.

(b) Maximize use of existing agency authorities to award contracts or grants to community organizations or other local entities to enhance mental-health and suicide-prevention services, such as outreach, education, and case management, to vulnerable Americans. Sec. 6.

General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect.

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