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For an overview of clinical research regulations in the United Kingdom internal medicine purchase betoptic 5ml without prescription, see the ClinRegs report: clinregs. Health and Social Care Act lications/research-governance(2012): framework-for-health-and-social. Good Research Practice: Principles and 100 Country Key Organizations Legislation Regulations Guidelines. Department of Health, Social Research Governance Framework for Services and Public Safety: Health and Social Care (Northern Ireland). Medical Devices Investigation for a Medical Device: (Amendment) Regulations 2008. Use of Personal Health Information in Medical Research General Public Consultation Final Report (2007). Keeping Research on Track: A Guide for Aboriginal and Torres Strait Islander Peoples about Health Research Ethics (2006): National Statement on Ethical Conduct Registry Research Council and the Department in Human Research, 3. Guidelines under Section 95 of the have privacy/data the Privacy Act 1988 (2014): Privacy Act 1988 (2014): protection laws: Guidelines Approved under Section jurisdictions/state-andSection 95A of the Privacy Act 95A of the Privacy Act 1988 (2014): territory-privacy-law 1988 (2014): Ministry of Health National Ethics Ethical Review Committee (2005) Committee on Clinical Research: Body Organ Donation Law (2004) China, People’s Republic of For an overview of clinical research regulations in China, see the ClinRegs report: clinregs. Special Review and Approval html Procedure for Drug Registration of the State Food and Drug Administration (2005): eng. Qualification and Evaluation of Clinical Trial Sites (2008) (Mandarin): Rules on the Administration of Report and Supervision of Adverse Drug Reactions (2010) (Mandarin): Ethical Review Application And 110 Country Key Organizations Legislation Regulations Guidelines Review Form 2. Regulations on Recall of tml Medical Devices (Interim), Article 37 (2011) (Mandarin): OpenDocument&bt= 0 India For an overview of the clinical research regulations in India, see the ClinRegs report: clinregs. Exemption for Academic Research and Animal Toxicity: General Statutory Rules 313(E) (2016) Devices 1. Compensation Formula for Clinical Trial Injury Other than Death (2014) :

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If in the methods section you listed the statistical tests and the p value that was deemed only (eg medications used for migraines order 5 ml betoptic free shipping, Though the difference between the treatment to indicate a statistically significant difference, don’t forgroups was statistically significant, we suspect that the get to address those in the results section. Finally, in the conclusions section you should indicate what rethe Discussion Section search questions should be answered next (eg, We are currently designing a study to determine whether the staWhen starting the discussion consider the research questistically significant difference identified in the present tion first. You posed the research question, explained your study significantly affects hospital mortality. Generic Construct for Writing the Discussion Section Paragraph Objectives Example Sentence 1 Describe the major findings of the report The main finding of our research is that, with our lung model, the Answer the research question moisture outputs of device A and device B were not different. Our findings were Use references to support your interpretation of your obtained under controlled laboratory conditions. Performance of these Describe the generalizability of your results to other devices beyond that time frame is unknown. Both systems can be used to provide humidification during interpretation of the findings short-term mechanical ventilation of adults. System A may improve mucociliary function, enhance secretion clearance, and reduce the incidence of ventilator-associated pneumonia. N Engl J Med 1978; tributed to the work but did not contribute sufficiently to earn 298(14):773–775. When authorship fails: a proposal to You must have permission from any individuals mentioned in make contributors accountable. Ann Intern keep acknowledgements short and to the point (eg, Thanks to Med 1986;104(2):269–274. Acad Emer Med 1999;6(4): sity of California at San Francisco, for her assistance with sta297–301. Uniform requirements for manuscripts submitted to biomedical jourThere are some simple rules that can assist the novice nals. International Committee of Medical Journal Editors (updated author in constructing a paper, and there are common pitNovember 2003). Nashville: Naning of a study is the best way to avoid problems at the tional Publishing Company; 1982:151–163. The purpose of this third updated and expanded edition remains to provide practical guidance for undertaking systematic reviews evaluating the effects of health interventions. It presents the different stages of the process and incorporates issues specific to reviews of diagnostic and prognostic tests, public health interventions, adverse effects and economic evaluations. Recognising that health care decision-making often involves complex questions that go beyond ‘does it work’, the guidance also includes information relating to how and why an intervention works. Reproduction of this book by photocopying or electronic means for non-commercial purposes is permitted. Our aim is to promote high standards in commissioning and conduct, by providing practical guidance for undertaking systematic reviews evaluating the effects of health interventions. Practitioners and decision-makers are encouraged to make use of the latest research and information about best practice, and to ensure that decisions are demonstrably rooted in this knowledge.

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Women treated with mastectomy are occurrence of invasive breast cancer in patients with atypical ductal appropriate candidates for breast reconstruction (see Principles of hyperplasia treated with tamoxifen medications band cheap betoptic 5 ml on-line. The primary endpoint 2 x 2 fashion to tamoxifen or not and whole breast radiation therapy or 88 was breast cancer–free interval. In addition, monitoring of disease relapse with any treatment team are the standard of care. The excised tissue detailing the written pathology report details conservation therapy is optimal as additional tissue sampling is needed these key factors. The accuracy of pathology reporting requires to verify true malignant disease warranting excision. Data from both national and local surveys show that menses does not necessarily correlate with fertility, and fertility may be as many as 50% of pathology reports for breast cancer are missing preserved without menses. All premenopausal patients should be some elements critical to patient management. Psychological distress can be women of childbearing potential should have a discussion with their impacted by body image and other factors. The offspring of pregnancies after treatment for breast cancer patients with hormone receptor-negative early-stage breast cancer. However, treatment for breast cancer, especially with cytotoxic positive disease have conflicting results with respect to the protective agents, may impair fertility. A bone scan is indicated in patients presenting with localized bone pain Additional Workup or elevated alkaline phosphatase. In general, patients with early-stage breast cancer undergo primary According to the panel, additional tests may be considered in patients surgery (lumpectomy or mastectomy) with or without radiation therapy. It may be reasonable to treat selected patients Mastectomy is indicated for patients who are not candidates for with invasive cancer (without extensive intraductal component) despite lumpectomy and those who choose to undergo this procedure over a microscopically focally positive margin with breast conservation lumpectomy. These differences Older Adult Oncology for special considerations for this population. For believes that current treatment decisions should be made based solely patients with clinically negative axillae who are undergoing mastectomy on H&E staining. In this study, there was no difference in these procedures may be considered optional in patients who have Version 4. Greater target dose homogeneity and Four randomized clinical trials have investigated hypofractionated whole sparing of normal tissues can be accomplished using compensators breast radiation schedules (39–42. A boost to the tumor bed is have demonstrated decreased in-breast recurrences with an additional recommended in patients with higher risk characteristics (such as age boost dose of radiation (by photons, brachytherapy, or electron beam) <50, high-grade disease, or patients with focally positive margins) in to the tumor bed. Depending on whether the patient has had confines of a high-quality, prospective clinical trial. Thirty-four Gy mastectomy depending on lymph node involvement (see Principles of in 10 fractions delivered twice per day with brachytherapy or 38. Locoregional a significant reduction in 15-year risk of breast cancer death (21% vs. However, the panel has noted that it may be have provided evidence for benefit of radiation therapy for only selected considered only for patients with high risk of recurrence.

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Community-derived data show that households make reasonable decisions when faced with difficult circumstances: they prefer hospitals when affordable and seek care at clinics and health centers when hospitals are too far away symptoms upper respiratory infection discount betoptic 5 ml on-line. This paper argues that formal recognition of their role by the government and by the conventional medical associations, as well as a targeted strategy to strengthen and build on the positive qualities evident in traditional medicine practices may be beneficial in safeguarding the well-being of the poor. Lambert (Consultant, PhD) and Kenneth Leonard (Professor, University of Maryland). This is detrimental: evidence suggests that to achieve an 80 percent rate of assisted deliveries, developing countries should 2 have at least 2. There is also evidence that even when health workers are present, the poor still have disproportionate access to their services. According to Kenyan health statistics, the prevalence and incidence of sickness for the country‘s 38 million people are similar for the poor and the 1 nonpoor. However, the response to sickness is markedly different across different socioeconomic groups. Further research is required to link such findings to a number of potential factors: the lack of available allopathic providers, discrimination in the provision of services, the inability of the poor to afford services, or the lack of trust that the poor place in conventional health workers. Many rural populations rely on the presence and services of traditional medical practitioners, who form part of the informal sector. The World Health Organization has estimated that traditional health care providers in developing countries provide primary health care needs for 80 percent of the rural populations. The lack of adequately skilled and affordable health workers gives traditional healers a de facto monopoly over health services provision in many, particular rural, communities. Another view is traditional healers flourish because they are charlatans who consistently dupe and take advantage of their clients. According to this view, traditional healers exhibit some or all of the following characteristics: They serve only the poor who cannot afford modern medicine; they serve the ignorant who do not know better; they cure patients who are not really sick or would have gotten better anyway; or they take advantage of a temporary placebo effect to collect payment before the patient feels ill again. Lincoln Chen and Alii et al, ―Human Resources for Health: Overcoming the Crisis,‖ Lancet 364 (2004): 1984–90. According to this view, traditional healers have access to therapies that are reasonable substitutes but rarely superior to modern therapies. They are able to turn these therapies into effective medicine because they live in the communities they serve, know the people they care for, accept payment in kind, take payment for cures rather than medicines, and take a holistic view of the well-being of their patients. This paper examines the role that traditional medical practitioners play in the provision of health services for the rural poor in Kenya, and discusses the need for regulating their practice and promoting the positive elements of such practice. The paper is organized as follows: the remainder of this chapter discusses the nature and methodology of the two surveys, which were carried out to inform this study. Each vignette was acted out by a male or female enumerator for the men‘s and women‘s groups, respectively.

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For the public to treatment 7th feb bournemouth buy 5 ml betoptic with visa be willing to participate in clinical research and to provide public funding, it needs to trust that such research is conducted according to strict ethical standards (1). We then turn to a number of ethical considerations including scientific misconduct, conflict of interest, authorship, and confidentiality. The principle of respect for persons requires investigators to obtain informed consent from research participants, to protect participants with impaired decision-making capacity, and to maintain confidentiality. Research participants are not passive sources of data, but individuals whose rights and welfare must be respected. The principle of beneficence requires that the research design be scientifically sound and that the risks of the research be acceptable in relation to the likely benefits. Risks to participants include both physical harm from research interventions and also psychosocial harm, such as breaches of confidentiality, stigma, and discrimination. The risks of participating in the study can be reduced, for example, by screening potential participants to exclude those likely to suffer adverse effects and monitoring participants for adverse effects. The principle of justice requires that the benefits and burdens of research be distributed fairly. Vulnerable populations, such as people with poor access to health care, those with impaired decision-making capacity, and institutionalized persons, may lack the capacity to make informed and free choices about participating in research. Traditionally, clinical research has been regarded as risky, and potential subjects have been thought of as guinea pigs who needed protection from dangerous interventions that would confer little or no personal benefit. Patients who seek promising new drugs for fatal conditions want increased access to clinical research, not greater protection (3). In addition, groups that are underrepresented on clinical research have suboptimal clinical care because of a weak evidence base. Children, women, and members of ethnic minorities historically have been underrepresented in clinical research. In addition, most universities require that all research on human subjects conducted by affiliated faculty and staff comply with these regulations, including research funded privately or conducted off-site. These federal regulations define research as ‘‘systematic investigation designed to develop or contribute to generalizable knowledge (4). Human subjects are living individuals about whom an investigator obtains either ‘‘data through intervention or interaction with the individual’’ or ‘‘identifiable private information. Usually these differences can be resolved through discussions or protocol modifications. They may place undue emphasis on consent forms and fail to scrutinize the research design. Ultimately, the judgment and character of the investigator are the most essential element for assuring that research is ethically acceptable. The ethical justification for such exemptions is that the research involves low risk, almost all people would consent to such research, and obtaining consent from each subject would make such studies prohibitively expensive or difficult. The Department of Health and Human Services publishes a list of types of research that are eligible for expedited review (7), which can be obtained at its website.

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Cases in literature have been associated with poorer prognosis than true cirrhosis with fatal outcome nearly always in a few months symptoms 9 weeks pregnancy generic betoptic 5ml mastercard. Cirrhosis on baseline imaging, pre-existing chronic liver disease, hepatitis B/C, and heavy alcohol use were exclusion criteria. Body: Background: Neutropenia is a common adverse event reported in cancer patients undergoing cytotoxic chemotherapy. Biosimilar development involves a series of comparisons between the proposed biosimilar and reference performed in a step-wise fashion to eliminate any concerns regarding the similarity of the medicines. Safety analyses included calculation of risk ratios for bone pain events, myalgia events and serious adverse events. Mater Adults Hospital, Brsibane, 2 3 Queensland, Australia; University of Queensland, Brisbane, Queensland, Australia and Griffith University, Southport, Queensland, Australia. Clinical trials and observational studies for all potential pharmacological and non-pharmacological interventions were included. Risk of bias for full-text papers was assessed using the Cochrane Risk of Bias Assessment or the modified Newcastle Ottawa score. Results: Of 706 records being identified, 601 unique citations were screened with 21 full text papers retrieved for assessment, and 16 studies included in the qualitative assessment. Pharmacological interventions which were investigated included calcium/magnesium infusion, glutamine, amifostine, goshajinkigan, omega 3 fatty acids, acetyl-L-carnitine, pregabalin, alpha-lipoic acid and minocycline. Non-pharmacological interventions included body mass index & lifestyle factors, electroacupuncture, exercise, limb hypothermia, carbon dioxide limb bathing and limb compression therapy. On subgroup analysis of trials investigating exercise, there was a benefit in the use of high intensity exercise versus low intensity exercise, particularly in patients <50 years old within a healthy weight range. Instituto de Investigación Sanitaria La Fe, Valencia, Spain; Servicio de Cardiología. Hospital 3 Universitario y Politécnico La Fe, Valencia, Spain and Servicio de Oncología Médica. There is not enough evidence about early detection and appropriate management of cardiotoxicity. Analytical biomarkers were measured each chemotherapy cycle and cardiology test were performed before starting chemotherapy, 3 months afterwards, and then every six months during 5 years. Levels of miR-133b, miR-21-5p and miR-210 may alert for a risk of cardiotoxicity and can help to make decisions about treatments. Patients received a pre-operative baseline L-Dex measurement followed by post-operative assessments at regular intervals. The median number of nodes removed was 19 (range: 5-41) and the median number of positive nodes was 3. Eighty five percent of patients underwent mastectomy and the remainder breast conserving therapy. The median number of nodes removed was 18 (range: 5-32) and the median number of positive nodes was two.

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Breast cancer mortality in participants mography in Northern Sweden: efects of the Norwegian Breast Cancer Screening 46 symptoms 8 days past ovulation discount 5ml betoptic. Screening mammogramammography in women with elevated breast Dense Breasts: Interim Report of a Prospeccamera in women at high risk for breast 30. Published OnlineFirst December 6, from disease occur in women not regularly tinues: Ultrasound in the screening of women screening of women at average risk of 27. San Antonio Breast Canand Sieverts, Oh My: A Guide for Discussing screening Society of North America. The Oncologist 2014;19:107–112 sitivity and specifcity of mammography study of breast cancer incidence in women with 28. Cancer mography and contrast enhanced tomosynassociated with breast cancer screening. Sardanelli F, Boetes C, Borisch B et al (2010) conservation in early breast cancer. Eur J Radiol 82(3):404–411 estimates in digital breast tomosynthesis with language review by Europa Donna–The 10-year follow-up results of two randomised mammography frst estimate of the beneft and harm balrelative to those in two-view full feld digiEuropean Breast Cancer Coalition (2015) Breast controlled trials. Colin C, Devouassoux-Shisheboran M, Sarination to distinguish high cancer risk women 29. Globocan Online Analysis agnosis also nested in pathologic misclasscreening using synthetically reconstructed Radiotherapy in breast cancer Whole-Breast Irradiation: A Randomized globocan. Early Breast Cancer Trialists’ Collaborative Comparative Analysis of Physician-Assessed en’s information. Lancet 2011; 378:1707 early breast cancer: results of a randomized clinstudy in 173,797 patients. Brkljacić B, Miletić D, Sardanelli F (2013) TherComparison of digital mammography alone tiveness of digital breast tomosynthesis comical trial in Lyon, France. J Clin Oncol 1997; 15:963 mography is not a feasible method for breast and digital mammography plus tomopared with digital mammography: Outcomes 2. Coll Antropol 37(2):589–593 synthesis in a population-based screenanalysis from 3 years of breast cancer screening. Hofvind S, Sørum R, Thoresen S (2008) Cancer Epidemiol 39(4):656–663 tomosynthesis in a population-based screening ing tool. Clin Radiol 71(2):141–150 Long-term complications associated with ence of patient, tumor and treatment factors Incidence and tumor characteristics of breast programme using independent double reading breast-conservation surgery and radioon the cosmetic results after breast-conserving cancer diagnosed before and after imple15. Ciatto S, Houssami N, Bernardi D et al (2013) abnormalities detected at screening mam4. Int J Cancer 137(9):2198–2207 Integration of 3D digital mammography with mography: a population-based study in the ized trial of pentoxifylline and vitamin E vs stan6. Lång K, Andersson I, Rosso A, Tingberg ultrasound and fne-needle aspiration cytology 5. A, Timberg P, Zackrisson S (2016) Perforto detect patients with extensive axillary lymph Fractionation for whole breast irradiation: 22881-10882 trial. Bartelink H, Maingon P, Poortmans P, et its relationship with tumor biomarkers in Breast cancer screening for women at average modality: results from the Malmö Breast 35.

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Our approach is novel in that it combines fat grafts with dermatocutaneous flaps for immediate reconstruction and utilizes serial fat grafts without pre expansion for complete delayed breast reconstruction symptoms 7 order betoptic 5ml otc. The technique has been successfully utilized to complete both immediate unilateral and bilateral breast reconstruction in a single stage in select patients and with serial fat grafts in others. Body: Background: To avoid tissue expander exposure following mastectomy flap necrosis, several methods for covering expander by autologous flap in cases of immediate breast reconstruction have been reported. These methods are classified into two groups, complete or partial expander coverage. Two methods have potential risks of postoperative complications following: insufficient lower pole expansion and cranial migration in complete coverage methods, and lateral migration in partial coverage methods. However, the comparisons of complication rates between these two methods have not been reported. This study aims to compare the incidence of expander exposure following mastectomy flap necrosis and expander migration between two methods. Methods: A retrospective review of 93 patients (99 breasts) who underwent immediate expander-based breast reconstruction was performed. Patients were divided into two groups, complete or partial expander coverage by autologous flaps. In partial coverage group, the lateral borders of pectralis major muscles were sutured to the mastectomy skin flaps. If the skin flap was too thin to be sutured, the serratus anterior muscro-fascial flap was dissected and sutured to the lateral border of pectralis major muscle to cover the expander completely. Demographics, intraoperative findings, and postoperative complications were compared between two groups. Results: Of the 99 breasts, 56 underwent complete expander coverage and 43 underwent partial coverage. Mastectomy flap necrosis rate was higher in the complete coverage group (Complete 14. Lateral migration rate was higher in the partial coverage group (Complete 0% versus Partial 9. There was no difference in cranial migration rate between two groups (Complete 12. Conclusions: the thinness of the mastectomy flaps was considered to provide the higher incidence of mastectomy flap necrosis in the complete coverage group. The complete expander coverage reduced lateral migration rate and prevented expander exposure in cases of mastectomy flap necrosis. Aichi Cancer Center Hospital, 2 3 Nagoya, Aichi, Japan; Aichi Cancer Center Hospital, Nagoya, Aichi, Japan and Nagoya University, Nagoya, Aichi, Japan. Two hundred fifty four early breast cancer pts underwent immediate artificial breast reconstruction from January 2014 to March 2017 in our institution. Thirty seven pts were excluded in this analysis because of preplanned the expander insertion. We evaluated the total cosmetic finding based on three categories of inframammary fold position, balance of both breast size and form at half year after operation.

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The central shaft medications for ibs buy betoptic once a day, connecting points A, C and D together, consists of two parts that are connected by a bayonet mount and accomodate a 12-gauge (2. Joints J16 and J17 are combined ball/revolute joints, that consist of three parts, shown in Figure 7. The ball part (ball radius 9 mm) is enclosed by a pair of identical socket halves that are interlocked by a revolute joint inspired by the bayonet mount. Each of the two socket parts are rigidly attached to the racks of the stepper motors in the same carrier. Finally, joints J14 and J15 are pin joints, together forming a universal joint which connects the rack of joint J5 to the needle holder. As for the base and carriers, 4 mm acrylic rods connect the different parts together. A manually-controlled distributor was developed for the Stormram 1 robot [46], and is also used to operate the Stormram 2 and 3 by visual servoing. As it is practically impossible to guide a biopsy needle in breast tissue by visual servoing alone, in the absence of realtime 7. This manifold can control the different robots programmatically towards given target coordinates in feed-forward fashion. Consequently, airflow limitations and transmission delays in the pneumatic lines restrict the motor’s stepping frequency to approximately 5 Hz for the manual manifold [46], and 10 Hz for the computerized one. The desired end-effector configurations can be translated to actuator configurations, and vice versa. Frame Ψ0 is attached to the base of the robot, and ΨE is attached to the needle holder. The Stormram 3 pose is fully defined by this transformation, as 0 all joint centroids are rigidly attached to either Ψ0 or ΨE. The actuated joint configuration vector v = (`, `, `, `, `1 2 3 4 5) defines the state of the five prismatic actuators. A length `i represents the distance between the joint centroids that are linked by the i-th prismatic joint. The third step is to apply the constraint put by the serial kinematic chain J12 − J13 − J5 − J14 − J15. This chain has four free parameters (as J5 is fixed), thus fixing (6 − 4) = 2 degrees of freedom of ΨE, making the Stormram 3 a well-determined kinematic system. Unfortunately, there is no elegant way to express this last constraint mathematically without having to write out the full kinematic chain with all its joints. The fifth length, `5, can be approximated or numerically solved analogous to the forward kinematics problem problem.

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The same is true for any other information obtained in response to medications bipolar discount betoptic 5 ml with mastercard open-ended and closed questions. If you ask an open-ended question, you can develop any number of categories at the time of analysis. Both open-ended and closed questions have their advantages and disadvantages in different situations. To some extent, their advantages and disadvantages depend upon whether they are being used in an interview or in a questionnaire and on whether they are being used to seek information about facts or opinions. As a rule, closed questions are extremely useful for eliciting factual information and open-ended questions for seeking opinions, attitudes and perceptions. The choice of open-ended or closed questions should be made according to the purpose for which a piece of information is to be used, the type of study population from which information is going to be obtained, the proposed format for communicating the findings and the socioeconomic background of the readership. In a questionnaire, open-ended questions can provide a wealth of information provided respondents feel comfortable about expressing their opinions and are fluent in the language used. The researcher usually needs to go through another process – content analysis – in order to classify the data. In a questionnaire, open-ended questions provide respondents with the opportunity to express themselves freely, resulting in a greater variety of information. The disadvantage of free choice is that, in a questionnaire, some respondents may not be able to express themselves, and so information can be lost. As open-ended questions allow respondents to express themselves freely, they virtually eliminate the possibility of investigator bias (investigator bias is introduced through the response pattern presented to respondents). On the other hand, there is a greater chance of interviewer bias in openended questions. Advantages and disadvantages of closed questions One of the main disadvantages of closed questions is that the information obtained through them lacks depth and variety. There is a greater possibility of investigator bias because the researcher may list only the response patterns that s/he is interested in or those that come to mind. Even if the category of ‘other’ is offered, most people will usually select from the given responses, and so the findings may still reflect researcher bias. In a questionnaire, the given response pattern for a question could condition the thinking of respondents, and so the answers provided may not truly reflect respondents’ opinions. Rather, they may reflect the extent of agreement or disagreement with the researcher’s opinion or analysis of a situation. The ease of answering a ready-made list of responses may create a tendency among some respondents and interviewers to tick a category or categories without thinking through the issue.

References:

  • https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103293s5130lbl.pdf
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  • http://www.floridahealth.gov/diseases-and-conditions/disease-reporting-and-management/disease-reporting-and-surveillance/_documents/gsi-diphtheria.pdf
  • https://www.seymourjohnson.af.mil/Portals/105/Documents/MDG%20Docs/AFI%2048-123.pdf
  • https://www.healthinfotranslations.org/pdfDocs/Vaginal_Infection_SP.pdf