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1 alence and intensity in schoolchildren after drug administration).
2 gency use authorization by the U.S. Food and Drug Administration.
3 sive therapy within the 30 days before study drug administration.
4 ncy Use Authorization from the U.S. Food and Drug Administration.
5 ATATE PRRT was approved by the U.S. Food and Drug Administration.
6  users, manufacturers, and the U.S. Food and Drug Administration.
7 ren who had received multiple rounds of mass drug administration.
8  been validated for approval by the Food and Drug Administration.
9 onditions, as recommended by the US Food and Drug Administration.
10  profiles that were dependent on the time of drug administration.
11 ntly approved by the United States' Food and Drug Administration.
12  and a hormone replacement protocol prior to drug administration.
13 r metabolic profile following both routes of drug administration.
14 ic therapies are approved by the US Food and Drug Administration.
15 geted for elimination by mass (antifilarial) drug administration.
16 he European Medicines Agency and US Food and Drug Administration.
17 e authorization (EUA) from the U.S. Food and Drug Administration.
18  ENDO trial (NCT01728116) by the US Food and Drug Administration.
19 ut emptying can be as effective as anorectic drug administration.
20 e events were thought to be related to study drug administration.
21 atment cycles lasted 28 days, with 5 days of drug administration.
22  clinical development all require parenteral drug administration.
23 ithout a therapy approved by the US Food and Drug Administration.
24 sation period followed by vehicle control or drug administration.
25 lergies had been approved by the US Food and Drug Administration.
26                   In the 3 months after mass drug administration, 10 614 attended outpatient clinics
27 ch, 29 drugs are approved by the US Food and Drug Administration, 12 are in clinical trials and 28 ar
28 es C ice bath for 2 min) pre- and 5 min post-drug administration (20 mg ketamine or saline).
29 gency Use Authorization from the US Food and Drug Administration(3,4).
30 tric has been operationalized on an Food and Drug Administration 510(k)-cleared platform otherwise us
31 nd were recently approved by the US Food and Drug Administration(7).
32 he patient artery due to glucose rinse after drug administration accounted for up to 10.7% of the tot
33 arios: (1) implementation of the US Food and Drug Administration added sugar labeling policy (sugar l
34 nes Agency [EMA] EudraVigilance; US Food and Drug Administration Adverse Event Reporting System [FAER
35  million reports from United States Food and Drug Administration Adverse Event Reporting System and p
36 ohort study was conducted using the Food and Drug Administration Adverse Event Reporting System betwe
37 vent reports form the United States Food and Drug Administration Adverse Event Reporting System to co
38                                 The Food and Drug Administration allows for using surrogate endpoints
39                                 The Food and Drug Administration Amendments Act (FDAAA) of 2007 now r
40 ls were recently approved by the US Food and Drug Administration and are poised to enter the practice
41 es are already approved by the U.S. Food and Drug Administration and are readily available.
42 e simultaneous approval by the U.S. Food and Drug Administration and Centers for Medicare and Medicai
43                                     Food and Drug Administration and company websites were searched f
44 ns classically occur more than 6 hours after drug administration and include life-threatening conditi
45  have received approval from the US Food and Drug Administration and more than 80 others are currentl
46  medicine requires accurate technologies for drug administration and proper systems pharmacology appr
47 een an important focus for the U.S. Food and Drug Administration and the 2016 Congressional 21st Cent
48  glucose-lowering therapies, the US Food and Drug Administration and the Committee for Medicinal Prod
49 e regulatory guidelines by the U.S. Food and Drug Administration and the European Medical Agency requ
50 e 46 algorithms that currently have Food and Drug Administration and/or Conformite Europeenne approva
51 en of drugs approved by the FDA (US Food and Drug Administration) and identified entry inhibitors of
52 occurring more than 1 hour after the initial drug administration), and the reaction severity.
53 blic, manufacturer's websites, U.S. Food and Drug Administration, and Centers for Disease Control and
54 r are critically dependent on the pattern of drug administration, and exacerbated by interruption of
55 work developed by the United States Food and Drug Administration; and quantitative approaches such as
56 in this study will likely gain U.S. Food and Drug Administration approval for commercialization in th
57 y that will likely pave the way for Food and Drug Administration approval in the United States.
58 osing guidelines and have led to US Food and Drug Administration approval of adult dosing down to 20
59   These findings supported the U.S. Food and Drug Administration approval of gadobutrol-enhanced CMR
60  aromatase inhibitor (AI), given US Food and Drug Administration approval of three agents in this cla
61 periencing a renaissance, with U.S. Food and Drug Administration approval recently being obtained for
62 en universally accepted or obtained Food and Drug Administration approval.
63 d on the review of the evidence, US Food and Drug Administration approvals, and consensus when eviden
64 gainst SARS-CoV-2, but it is not US Food and Drug Administration approved and currently is being test
65            Platinum segments are US Food and Drug Administration approved and provide benefits of pla
66   In the field of dentistry, the US Food and Drug Administration approved BoNT-A for the treatment of
67 nderrepresented among United States Food and Drug Administration approved drugs.
68        On August 16, 2019, the U.S. Food and Drug Administration approved expanding the indication fo
69                                 The Food and Drug Administration approved the first ICI, ipilimumab,
70                        In 2012, the Food and Drug Administration approved the use of bedaquiline fuma
71 three chemokine receptors with a US Food and Drug Administration approved therapeutic agent, the smal
72 l medication, is United States (US) Food and Drug Administration approved to treat CL caused by Leish
73                        In 2012, the Food and Drug Administration approved use of bedaquiline fumarate
74 burnetii infections but is not U.S. Food and Drug Administration approved.
75                                     Food and Drug Administration approved.
76                IMPs, composed of US Food and Drug Administration-approved 500nm carboxylated-poly(lac
77  an acute low dose of perampanel, a Food and Drug Administration-approved AMPA receptor (AMPAR) antag
78                 Manufacturers of US Food and Drug Administration-approved and commercially available
79  combination with other existing US Food and Drug Administration-approved anti-cancer modalities.
80  Bortezomib and carfilzomib are two Food and Drug Administration-approved anticancer drugs, and prote
81                        Bupropion, a Food and Drug Administration-approved antidepressant and smoking
82                                 The Food and Drug Administration-approved antifungal agent, itraconaz
83 e counseling sessions and choice of Food and Drug Administration-approved cessation medication (nicot
84 gh positivity rate as compared with Food and Drug Administration-approved currently available imaging
85                           Recently, Food and Drug Administration-approved cystic fibrosis protein tra
86 raviroc, an inhibitor of CCR5 and a Food and Drug Administration-approved drug against HIV infection,
87 tinib, a necroptosis-inhibiting and Food and Drug Administration-approved drug for lymphocytic leukem
88 e time of this writing, there is no Food and Drug Administration-approved drug for vitiligo.
89  scientists on repurposing existing Food and Drug Administration-approved drugs that inhibit viral en
90                                  As Food and Drug Administration-approved drugs, the tetracyclines co
91 ics search for structurally similar Food and Drug Administration-approved drugs.
92 idepressants, or a drug that is not Food and Drug Administration-approved for their age.
93 ively termed JAK inhibitors, are US Food and Drug Administration-approved in a few autoimmune/inflamm
94  population that reflected the U.S. Food and Drug Administration-approved instructions for use (enrol
95 g periocular condition for which no Food and Drug Administration-approved medical therapy is availabl
96  option, including that for the now Food and Drug Administration-approved peanut OIT product Palforzi
97 SIGNIFICANCE STATEMENT There are no Food and Drug Administration-approved pharmacotherapies to preven
98                                     Food and Drug Administration-approved prescribing information des
99 t of RT activity implicates already Food and Drug Administration-approved RT inhibitors as possible n
100 initial potency screening of 7 U.S. Food and Drug Administration-approved statins, we examined pitava
101 asia has led to development of U.S. Food and Drug Administration-approved targeted therapies, such as
102                To date, there is no Food and Drug Administration-approved targeted therapy for advanc
103                     An example of a Food and Drug Administration-approved theranostic pair is the (68
104 igh morbidity and mortality, and no Food and Drug Administration-approved therapies.
105 ived expedited approval from the US Food and Drug Administration as a breakthrough drug for a rare di
106 CCQ) has been qualified by the U.S. Food and Drug Administration as a Clinical Outcome Assessment and
107 he European Medicines Agency and the Federal Drug Administration as an option for sorafenib-resistant
108 2643 for UCSF) were approved by the Food and Drug Administration as the first drug for PET imaging of
109 ical device regulatory agencies, US Food and Drug Administration, as well as payers, that we believe
110 pain response, as defined by the US Food and Drug Administration: at least a 30% decrease in the week
111 docrine therapy submitted to the US Food and Drug Administration before Jan 1, 2019, in support of ma
112 ancers that were approved by the US Food and Drug Administration between Jan 1, 2009, and Dec 31, 201
113 ere interpreted using United States Food and Drug Administration breakpoints.
114 lemented alone, was less effective than mass drug administration, but could provide additive impact i
115 ered capsule could produce longer-term local drug administration by intravitreal injection compared t
116 ith automatic postprocessing and US Food and Drug Administration/CE clinical approval, it can be a cl
117 form and has recently received U.S. Food and Drug Administration clearance.
118 yphilis, the development of direct, Food and Drug Administration-cleared T. pallidum NAATs should be
119                                 The Food and Drug Administration-defined primary efficacy endpoint wa
120 n, intravenous versus intraosseous route for drug administration during cardiac arrest, point-of-care
121 ions have been approved by the U.S. Food and Drug Administration during the last 30 years.
122 r a continuous flow of warm media,and 10 muM drug administration effect was detected with high spatio
123  available drugs are not well-suited to mass drug administration efforts, so new treatments are urgen
124  Initial implementation of the U.S. Food and Drug Administration EFS program has been successful, but
125  is also now permitted through U.S. Food and Drug Administration Emergency Use Authorization.
126 erall symptom relief, when using US Food and Drug Administration/European Medicines Agency recommende
127 he daily dose recommended by the US Food and Drug Administration (FDA) and European Medicines Agency
128 pared to that of BMD following U.S. Food and Drug Administration (FDA) and International Standards Or
129  and working with the United States Food and Drug Administration (FDA) and other regulatory agencies
130        On September 27-28, 2018 the Food and Drug Administration (FDA) and the Critical Path Institut
131 c assay that receives United States Food and Drug Administration (FDA) approval can be a slow and dif
132 eir accelerated, tissue-agnostic US Food and Drug Administration (FDA) approval for adult and pediatr
133 inia pestis, are needed, as past US Food and Drug Administration (FDA) approvals were not based on cl
134                   Although the U.S. Food and Drug Administration (FDA) approved for transport and cul
135 d be offered treatments that are US Food and Drug Administration (FDA) approved in the upfront and th
136 ch have been designated by the U.S. Food and Drug Administration (FDA) as "breakthrough therapies" fo
137 erapeutic agents approved by the US Food and Drug Administration (FDA) between 2009 and 2018 to estim
138 ) LC-MS C62-A document and the U.S. Food and Drug Administration (FDA) Bioanalytical Method Validatio
139                        In 2016, the Food and Drug Administration (FDA) changed labeling regarding met
140 of the rules explains successful US Food and Drug Administration (FDA) de novo authorization of an ex
141 ceived barriers to such access, the Food and Drug Administration (FDA) developed a model drug facts l
142 EDLINE, and publicly available U.S. Food and Drug Administration (FDA) drug reviews, all reported CVD
143                       Although U.S. Food and Drug Administration (FDA) drugs are approved for the tre
144 lar assays for SARS-CoV-2 under the Food and Drug Administration (FDA) Emergency Use Authorization (E
145                               While Food and Drug Administration (FDA) emergency use authorization (E
146 en developed and approved by the US Food and Drug Administration (FDA) for human use.
147 ays approved or cleared by the U.S. Food and Drug Administration (FDA) for in vitro diagnostic use, a
148 ut the evidence required by the U.S.Food and Drug Administration (FDA) for new approvals of opioid an
149 and searched the homepage of the US Food and Drug Administration (FDA) for pregnancy exposure reports
150 h treatments are approved by the US Food and Drug Administration (FDA) for r/r ALL (CD19CAR T-cell ap
151 cy use authorization (EUA) from the Food and Drug Administration (FDA) for the diagnosis of severe ac
152 mal tests currently approved by the Food and Drug Administration (FDA) for the diagnosis of syphilis
153                            The U.S. Food and Drug Administration (FDA) has granted emergency use auth
154                              The US Food and Drug Administration (FDA) has led the Sequencing Quality
155 ic drug that was approved by the US Food and Drug Administration (FDA) in 1985.
156 ing vaping products examined by the Food and Drug Administration (FDA) in this investigation have bee
157        A major challenge for the US Food and Drug Administration (FDA) is to achieve an appropriate b
158                              The US Food and Drug Administration (FDA) issued a new proposed rule in
159 accine from phase 1 through to U.S. Food and Drug Administration (FDA) licensure was tracked.
160 on into the uncharted waters of the Food and Drug Administration (FDA) new-drug application (NDA) pro
161                         Neither the Food and Drug Administration (FDA) nor the Clinical and Laborator
162 nidase-zzxf) was approved by the US Food and Drug Administration (FDA) on June 29, 2020.
163 nnected with the role that the U.S. Food and Drug Administration (FDA) plays in its regulation of neu
164 ion at 48 weeks according to the US Food and Drug Administration (FDA) snapshot analysis.
165 teria decreased over time following Food and Drug Administration (FDA) TCS bans.
166 hthalmic Devices Panel (ODP) of the Food and Drug Administration (FDA) to determine whether a relatio
167 ency use authorization (EUA) by the Food and Drug Administration (FDA) to identify SARS-CoV-2 positiv
168                                     Food and Drug Administration (FDA) warned that administration of
169 e event reports submitted to the US Food and Drug Administration (FDA) were analyzed to map the safet
170 ry Standards Institute (CLSI), U.S. Food and Drug Administration (FDA), and European Committee on Ant
171 edicines Agency (EMA), 16 by the US Food and Drug Administration (FDA), and ten by the Japan Pharmace
172 tam is not yet approved by the U.S. Food and Drug Administration (FDA), clinicians can administer thi
173 or government agencies, such as the Food and Drug Administration (FDA), to secure safe use of deep le
174 ly 330-fold higher potency than the Food and Drug Administration (FDA)-approved anti-TcdB monoclonal
175           Based on these data, a US Food and Drug Administration (FDA)-approved clinical trial has be
176 man brain tumor cell line to screen Food and Drug Administration (FDA)-approved compounds that specif
177 ound is structurally related to the Food and Drug Administration (FDA)-approved drug fluoxetine-which
178 nical evidence with nilotinib, a US Food and Drug Administration (FDA)-approved drug for leukemia, in
179 nic mice using AAV-PKR-K296R or the Food and Drug Administration (FDA)-approved drug metformin, decre
180                   In this study, an Food and Drug Administration (FDA)-approved drug, diflunisal, was
181                                     Food and Drug Administration (FDA)-approved gadolinium-based cont
182  posttransplant with Anakinra, a US Food and Drug Administration (FDA)-approved IL-1R antagonist; or
183     However, there are currently no Food and Drug Administration (FDA)-approved pharmacotherapies.
184 roximately 12,000 clinical-stage or Food and Drug Administration (FDA)-approved small molecules to id
185  A lead example is colchicine, a US Food and Drug Administration (FDA)-approved treatment for inflamm
186  the problem there are currently no Food and Drug Administration (FDA)-approved treatments.
187                                     Food and Drug Administration (FDA)-approved vaccine labels.
188 cine vectors.IMPORTANCE To date, no Food and Drug Administration (FDA)-approved vaccines are availabl
189  resistance transmission, but no US Food and Drug Administration (FDA)-cleared assays for detection a
190  0.5 ng/mL as recommended by the US Food and Drug Administration (FDA).
191 g as regulated by the United States Food and Drug Administration (FDA).
192 hilis test currently cleared by the Food and Drug Administration (FDA).
193  <50 copies/mL; intent-to-treat; US Food and Drug Administration [FDA] snapshot) at week 48; particip
194 hibitors (HDACi) approved by the US Food and Drug Administration for cutaneous T-cell lymphoma (CTCL)
195 ergency Use Authorization by the US Food and Drug Administration for hospitalized COVID-19 patients.
196  are 3 therapies approved by the US Food and Drug Administration for managing ATTR amyloidosis, depen
197 ategy (REMS) program imposed by the Food and Drug Administration for mifepristone.
198 TQ) was recently approved by the US Food and Drug Administration for prophylaxis of malaria and, in a
199 eucel (axi-cel) was approved by the Food and Drug Administration for relapsed aggressive B-cell non-H
200 t have already been approved by the Food and Drug Administration for targeting mRNAs and discuss the
201 t has recently been approved by the Food and Drug Administration for the management of complicated ur
202 ropean Medicines Agency or the U.S. Food and Drug Administration for the management of moderate to se
203 antibiotic that was approved by the Food and Drug Administration for the treatment of CABP in adults.
204 have been developed and approved by Food and Drug Administration for the treatment of non-small-cell
205  approved in March, 2019, by the US Food and Drug Administration for the treatment of relapsing multi
206 mab (anti-IL-6R) is approved by the Food and Drug Administration for treatment of cytokine storm asso
207  that has been approved by the U.S. Food and Drug Administration for treatment-resistant depression.
208  channel blocker approved by the US Food and Drug Administration for use in the treatment of arrythmi
209 d treatment strategies rely on periodic mass drug administration (generally with albendazole or meben
210 nd highly recommended in current US Food and Drug Administration guidelines.
211                        Ivermectin-based mass drug administration has emerged as a promising strategy
212 elicits severe side effects and the Food and Drug Administration has issued many warnings about their
213                     As such, the US Food and Drug Administration has published a guidance to encourag
214 se of the regulatory agencies of US Food and Drug Administration, Health Canada and Food Standard Aus
215 dministration, or blood levels 2 hours after drug administration higher than 10, 250, or 1200 ng/mL,
216 genic drug that was approved by the Food and Drug Administration in 2012 to treat patients with castr
217 ersely, the iStent, approved by the Food and Drug Administration in 2012, increased to represent 57.9
218 DCS observed in LF to inform the US Food and Drug Administration in a device registration decision.
219 harmacokinetic advantage over intra-arterial drug administration in a preclinical model of liver canc
220 rs as point of care devices to customize the drug administration in Alzheimer's disease.
221 rganization recommended three rounds of mass drug administration in districts where the prevalence of
222 n of signaling pathways in mice subjected to drug administration in vivo.
223 st-in-human, investigator-initiated Food and Drug Administration Investigational Device Exemption stu
224 transfusion through the traditional Food and Drug Administration investigational new drug pathway.
225 How this might be influenced by the route of drug administration is not known.
226  approved by the FDA (United States Food and Drug Administration) is the prostate specific antigen (P
227 el-free identification of PG by the Food and Drug Administration, it becomes crucial to educate the s
228  saturating levels, a common scenario during drug administration, it may cause the contrary of the de
229                         Despite the Food and Drug Administration label recommendation to avoid rivaro
230                                A US Food and Drug Administration-led environmental assessment, which
231 dministration, or blood levels 2 hours after drug administration levels between 7 and 10, 150 and 250
232 stem and the use of any alternative route of drug administration like nose-to-brain drug delivery cou
233         Results suggest that the US Food and Drug Administration made no progress in setting mandator
234                                     Food and Drug Administration mandated CT studies to understand th
235 ntinued need for investment in both the mass drug administration (MDA) and morbidity management progr
236          Our aim was to assess biannual mass drug administration (MDA) applied alone or with compleme
237  of ivermectin have been distributed in mass drug administration (MDA) campaigns globally over the pa
238  programmatic implementation details of mass drug administration (MDA) campaigns.
239 ntegrated implementation of large-scale mass drug administration (MDA) for neglected tropical disease
240 immunoassay before and after ivermectin mass drug administration (MDA) for scabies in the Solomon Isl
241 revalence and intensity of infection to mass drug administration (MDA) for schistosomiasis.
242 ed in trials investigating azithromycin mass drug administration (MDA) for trachoma control has been
243      Onchocerciasis elimination through mass drug administration (MDA) is hampered by coendemicity of
244           The objective of mass antimalarial drug administration (MDA) is to eliminate malaria rapidl
245                               Trials of mass drug administration (MDA) of azithromycin (AZM) report r
246 en done of patterns of treatment during mass drug administration (MDA) to control neglected tropical
247 mmation-follicular (TF) and discontinue mass drug administration (MDA) with oral azithromycin.
248 herefore debatable whether azithromycin mass drug administration (MDA), the recommended antibiotic tr
249 f antibody status, especially following Mass Drug Administration (MDA), which is critical to understa
250         One solution to this problem is mass drug administration (MDA), with success depending on ade
251 nced surveillance system, two rounds of mass drug administrations (MDAs) per year over two years (pha
252 due in part to important efforts by Food and Drug Administration, National Institutes of Health, Amer
253 which has led to approval by the US Food and Drug Administration of multiple agents in several cancer
254  targeted agents approved by the US Food and Drug Administration, olaparib for germline BRCA-mutated
255 etween label restrictions by the US Food and Drug Administration on first-line immunotherapy for adva
256 used to determine the effect of prophylactic drug administration on glutamatergic activity in CA3.
257 so investigated the effects of antipsychotic drug administration on SV2A levels in Sprague-Dawley rat
258 are discussed including the optimal route of drug administration, optimal number of drugs constitutin
259  Tac, CsA blood trough levels 12 hours after drug administration, or blood levels 2 hours after drug
260  Tac, CsA blood trough levels 12 hours after drug administration, or blood levels 2 hours after drug
261 but it was not approved by the U.S. Food and Drug Administration owing, in part, to its structural si
262                                        After drug administration, participants performed decision tas
263 Elimination Centre started programmatic mass drug administration (pMDA) campaigns with dihydroartemis
264 tentially teratogenic or fetotoxic (Food and Drug Administration pregnancy category D/X) cardiac-rela
265  noninferior to linezolid using the Food and Drug Administration primary endpoint of early clinical r
266                     In 2015, the US Food and Drug Administration published revised guidance that reco
267                              The US Food and Drug Administration recommends assessing CABP symptom re
268                                 The Food and Drug Administration recommends that food workers infecte
269 oupled organ chips may improve the design of drug-administration regimens for phase-I clinical trials
270 rospective, multicenter, single-arm Food and Drug Administration-regulated investigational device exe
271 ication of optimal schedules for combination drug administration relies on accurately estimating the
272  the most common and easiest route of ocular drug administration, representing the treatment of choic
273 a value far exceeding the recent US Food and Drug Administration-required cutoff of 12.0 for designat
274                                     Food and Drug Administration review data, and product labels that
275 al Trial), published literature, US Food and Drug Administration review documents, healthcare claims,
276 ate the effectiveness of reactive focal mass drug administration (rfMDA) and reactive focal vector co
277  followed by one year of reactive focal mass drug administrations (rfMDAs) (phase II, September 2017-
278 dings signal the potential importance of the drug administration route during resuscitation that meri
279  found no significant effect modification by drug administration route for amiodarone or lidocaine in
280 imicrobials were approved under the Food and Drug Administration's Animal Efficacy Rule.
281 mab worldwide were obtained from US Food and Drug Administration safety databases and the medical lit
282 m >=2 hours before to >=48 hours after study drug administration (SDA) were analyzed for seizures.
283 A <50 copies/mL (responders) by the Food and Drug Administration Snapshot algorithm (intent-to-treat
284 1 RNA >=50 copies/mL at week 48 (US Food and Drug Administration Snapshot algorithm) in the intention
285 er milliliter or higher at week 48 (Food and Drug Administration snapshot algorithm).
286 50 copies per mL at week 144, by US Food and Drug Administration Snapshot algorithm, analysed in the
287 -1 RNA copies per mL at week 48 (US Food and Drug Administration snapshot algorithm; non-inferiority
288                        We used a US Food and Drug Administration snapshot approach and a margin of 10
289 entify compounds approved by the US Food and Drug Administration that reduce activity of caspases 3 a
290 ates and Europe, patients, the U.S. Food and Drug Administration, the National Institutes of Health,
291  IPF.Methods: Working with the U.S. Food and Drug Administration through the Drug Development Tool Qu
292 th, our academic societies, and the Food and Drug Administration to continue support of these importa
293 ting resource established by the US Food and Drug Administration to support assessment of the safety
294 e agent has been approved by the US Food and Drug Administration to treat EoE.
295 istry and hematology), according to Food and Drug Administration toxicity scoring, to assess safety;
296                  A second phase III Food and Drug Administration trial is ongoing.
297 cy Use Authorization" from the U.S. Food and Drug Administration, were discussed.
298 alterations in protein levels, 2 hours after drug administration, which relates to the C(max) of BIO
299 ed agents have been approved by the Food and Drug Administration, with additional agents, most notabl
300  mebendazole, are currently used in STN mass drug administration, with many instances of low/reduced

 
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