scholarly journals Prolonged survival in a Patient with Chronic Myeloid Leukemia

1970 ◽  
Vol 39 (133) ◽  
pp. 180-181
Author(s):  
Ashutosh Shukla ◽  
O P Kalra
Keyword(s):  
Survival Rate ◽  
Chronic Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Prolonged Survival ◽  
Average Survival ◽  
Average Survival Rate

Patients with chronic myeloid leukemia treated with intermittent busulphan therapy havean average survival rate of 2 to 4 years. The authors report here a patient who continues tosurvive beyond one decade on busulphan therapy.

scholarly journals STUDY ON SURVIVABILITY OF NEWLY HATCHED LARVAE OF TWO SPECIES OF PEPPERMINT SHRIMP FED WITH DIFFERENT COMBINATIONS AND DENSITIES OF LIVE FOODS

2019 ◽  
Vol 14 (1) ◽  
pp. 15
Author(s):  
Indra Pratama ◽  
Hatim Albasri
Keyword(s):  
Survival Rate ◽  
Larval Stage ◽  
Survival Rates ◽  
The Third ◽  
Randomized Design ◽  
Average Survival ◽  
Peppermint Shrimp ◽  
Trial Treatment ◽  
Newly Hatched Larvae ◽  
Average Survival Rate

This study was aimed to evaluate different types and combinations of live foods in relation to the survivability of newly hatched Lysmata vittata and Lysmata intermedia larvae. The experiment consisted of three trials (different species, combinations, and densities of live foods) arranged in a completely randomized design. The first and second trials were subjected to L. vittata with three treatments for each trial (1A, 1B, 1C for trial-1; 1D, 1E, 1F for trial-2). The third trial consisted of two treatments (2A and 2B) tested on L. intermedia. Each treatment had three replicates. The results showed that the survival rates were low in all treatments. However, each treatment showed a significant effect (P<0.05) on the average survival rate of L. vittata and L. intermedia larvae. In the first trial, treatment 1C was the only one that had survived larvae after day 35 with 4.44% of final average survival rate (FASR). Four of the larvae reached the post-larval stage. In the second trial, treatment 1F showed a better condition than the other treatments with 5.56% FASR. Nevertheless, no larvae in the second trial had transformed to post-larval stage before the experiment ended at day 46. In the third trial, no larvae survived to reach the post-larval stage. In spite of this, treatment 2B had better daily average survival rate (DASR) than treatment 2A. This research concludes that the use of copepods as live food at an early larval stage and Artemia at a later stage is relatively more effective to improve the survival rate of peppermint shrimp larvae.

scholarly journals Mortality of Atta sexdens rubropilosa (Hymenoptera: Formicidae) workers in contact with colony waste from different plant sources

2009 ◽  
Vol 100 (1) ◽  
pp. 99-103 ◽  
Author(s):  
F.G. Lacerda ◽  
T.M.C. Della Lucia ◽  
O.L. Pereira ◽  
L.A. Peternelli ◽  
M.R. Tótola
Keyword(s):  
Survival Rate ◽  
Trichoderma Viride ◽  
Pathogenic Microorganisms ◽  
Atta Sexdens ◽  
Atta Sexdens Rubropilosa ◽  
Average Survival ◽  
Ligustrum Japonicum ◽  
Acalypha Wilkesiana ◽  
Plant Sources ◽  
Average Survival Rate

AbstractThe objective of this work was to study the effect of colony waste on the mortality of workers of Atta sexdens rubropilosa Forel colonies fed with different plant substrates. Eight nests were used; two colonies each were fed with Acalypha wilkesiana Müller.Arg, Ligustrum japonicum Thunb, Eucalyptus urophylla S.T. Blake or a mixture of the three substrates in equal proportions. Irrespective of diet, being kept with waste led to higher mortality. However, workers that were kept in contact with waste produced by colonies fed Acalypha had higher average survival rate and later death when compared with workers from the other treatments. Workers from the Eucalyptus-fed colonies had the lowest survival rate and 50% of them died within four days of exposure to Eucalyptus waste. Trichoderma viride Pers. ex Gray, a fungus garden antagonist, and the entomopathogen Aspergillus flavus Link. ex Gray were present in the colonies supplied with all plants. The largest fungus diversity was verified in the waste of colonies fed Acalypha and the mixture of Acalypha, Ligustrum and Eucalyptus. Therefore, antibiotic properties of Acalypha did not reduce contaminant diversity but apparently minimized effects of pathogenic microorganisms present in the waste such as Asp. flavus. This may explain the highest survival rate of workers in this treatment.

A Retrospective Survey of Imatinib Mesylate Treatment for Chronic Myeloid Leukemia in a Northern France Region.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4800-4800
Author(s):  
Selim Corm ◽  
Ariane Leroyer ◽  
Mathieu Wemeau ◽  
Bruno Bregman ◽  
Abderrahim Oukessou ◽  
...  
Keyword(s):  
Survival Rate ◽  
Chronic Myeloid Leukemia ◽  
Imatinib Mesylate ◽  
Myeloid Leukemia ◽  
Real Life ◽  
Chronic Phase ◽  
Disease Stage ◽  
Northern France ◽  
Advanced Phase

Abstract Objective: To describe the use and results of imatinib mesylate (IM) treatment for chronic myeloid leukemia (CML) in the Nord-Pas de Calais Region in Northern France (~ 4 millions inhabitants). Methods: we identified all IM treated patients (pts) within the population of all confirmed diagnosis of CML occurred during the period 1985–2004. IM resistance (haematological and cytogenetic imatinib failure and suboptimal response) was evaluated according to the European LeukemiaNet consensus. Results: 302 pts (38.6% of the global cohort of diagnosis) were included in this retrospective study. If we consider new diagnosis occurred after Januar 1st 2001, 163 pts (90.6%) have been treated by IM. At the initiation of IM: 18 pts (6%) were in advanced phase (accelerated and blastic), 245 pts (81,1%) in chronic phase (CP) (with Ph+ metaphases &gt; 35%), 35 (11,6%) had major cytogenetic response (MCyR) obtained with interferon (IFN) or bone marrow transplantation (BMT). Four pts (1,3%) had an unknown status. The percentage of alive pts at the last update (December 31th 2005) according to the disease stage at initiation of treatment is given in the table 1.In the sample of 245 CP pts, 139 (56.7%) had been previously treated by IFN, the median CML duration prior to IM was 4.7 months [0–174], the median IM treatment duration was 31.3 months [0.5–72.3] and the median follow-up after IM initiation was 36 month [5.2–72.3]. 214 pts (87.30%) were alive at the last update with 169 (79%) still on IM and 161 (75.2%) on IM as monotherapy. The median and mean IM daily doses of alive pts are 400 mg and 409.5 mg, respectively. Seventeen pts (6.9%) stopped IM for intolerance. The haematological and cytogenetic follow-up was informative for 206 CP pts (84.1%): MCyR 155 pts (75.2%) and CCyR 144 pts (69.9%). IM resistance occurred in 73 (35.4%) of these 206 evaluable pts, including 23 (11.1%) accelerations and blastic transformations. In the subgroup of IM resistant pts 47 (64.4%) have increased their IM posology. The mean of the maximum daily dose in the resistant subgroup was 607.5 mg (median 600 mg). BCR-ABL kinase domain mutations were found in 15 (20.5%) pts amoung IM resistant population. The estimated 5-years survival rate of the CP pts is 81.3%. Previous treatment by IFN doesn’t influence significantly the survival, nor the duration of the disease before IM initiation, even if we found a trend for a better survival when this period was inferior to 6 months (5 years survival rate 90.4% vs 77.5%, p=0.16). BMT was performed for 31 pts (10.3%) including 19 pts (6.3%) after the initiation of IM therapy. Conclusion: these real life observations show the large use of IM in the last years and its great impact on the management and the survival of CML pts. IM resistance occurs in 1/3 of pts but the disease duration prior to IM is heterogeneous. An increase of IM dose has been tried in most IM resistant pts. The response to the different therapy adaptations is under study and will be presented. The vast majority of pts are still on IM therapy at the last update. Table 1

DEVELOPMENT OF AN INTRODUCTION PROTOCOL FOR STRAWBERRY PLANTS INTO IN VITRO CULTURE

2020 ◽  
Vol 5 (86) ◽  
pp. 45-50
Author(s):  
O.V. Mazneva ◽  
◽  
L.V. Tashmatova ◽  
T.M. Khromova ◽  
V.V. Shakhov ◽  
...  
Keyword(s):  
Survival Rate ◽  
In Vitro Culture ◽  
Plant Material ◽  
Survival Rates ◽  
Strawberry Plant ◽  
Active Growth ◽  
High Viability ◽  
Average Survival ◽  
Average Survival Rate

The research was conducted in order to develop an effective protocol for introducing strawberry plants into in vitro culture. The objects of the research were the most popular varieties of strawberries of domestic and foreign selection: Tsaritsa, Bereginya, Florence, Frida, Kimberly, etc. Mercurial preparations mertiolate at a concentration of 0.01% and sulema at a concentration of 0.1% were used as sterilizing agents. The isolation of explants was performed in several periods: the beginning of the growth was in February, active growth was in June, the decline of growth was in August. The studies have shown that the maximum aseptic cultures were obtained when processing strawberry plant material with mercurycontaining sulema preparation in the concentration of 0.1%. At the first stage of micropropagation, explants had a high viability during all periods of the isolation, the average survival rate for varieties was 74.8-80.7%. A significant influence of the genotype (varietal characteristics) on the survival rates of explants was noted. The number of explants suitable for cloning did not depend on the overall level of regeneration. Stabilization of the crop during winter introduction was much faster than in other periods. Using the winter term of the isolation of strawberry explants allowed to increase the yield of explants capable of further cloning, accelerate the stabilization of the culture in vitro and reduce the time for obtaining micro-plants suitable for planting in non-sterile conditions. On average, 75.2% of explants capable of further cloning for the varieties were obtained. As a result of the research, the conditions and methods for obtaining the largest number of viable sterile strawberry explants were worked out, which will be included into the process of reproduction in vitro and further research.

scholarly journals Failure to achieve a complete hematologic response at the time of a major cytogenetic response with second-generation tyrosine kinase inhibitors is associated with a poor prognosis among patients with chronic myeloid leukemia in accelerated or blast phase

Blood ◽  
2009 ◽  
Vol 113 (21) ◽  
pp. 5058-5063 ◽  
Author(s):  
Carmen Fava ◽  
Hagop M. Kantarjian ◽  
Elias Jabbour ◽  
Susan O'Brien ◽  
Nitin Jain ◽  
...  
Keyword(s):  
Survival Rate ◽  
Chronic Myeloid Leukemia ◽  
Tyrosine Kinase ◽  
Tyrosine Kinase Inhibitors ◽  
Myeloid Leukemia ◽  
Second Generation ◽  
Kinase Inhibitors ◽  
Cytogenetic Response ◽  
Blast Phase ◽  
Complete Hematologic Response

Abstract Second-generation tyrosine kinase inhibitors are effective in Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML). Occasionally, patients with Ph+ ALL, or accelerated phase (AP) or blast phase (BP) CML achieve a major cytogenetic response (MCyR) but not a complete hematologic response (CHR). We analyzed 126 patients with CML in AP or BP, or with Ph+ ALL treated with dasatinib or nilotinib after imatinib failure. Twenty patients received sequential treatment with both dasatinib and nilotinib for a total of 146 instances. CHR and MCyR rates were 54% and 37%, respectively in AP, 17% and 39% in BP, and 33% and 50% in Ph+ ALL. Failure to achieve a CHR at the time of achievement of a MCyR was associated with an inferior outcome, similar to that of patients without a MCyR (2-year survival rate, 37% and 35%, respectively). In contrast, patients with MCyR and concomitant CHR had a 77% 2-year survival rate. Twelve of 29 patients with MCyR without concomitant CHR later achieved a CHR; the 2-year survival rate for these patients was 55% compared with 22% for those who never achieved a CHR. These results suggest that achievement of a MCyR without concomitant CHR is associated with poor outcome.

scholarly journals PERTUMBUHAN AWAL KAYU MERAH (Pterocarpus indicus Willd) PADA PLOT KONSERVASI EX-SITU DI GUNUNGKIDUL UMUR 2 TAHUN

2020 ◽  
Vol 14 (2) ◽  
pp. 129-135
Author(s):  
Yuliah Yuliah ◽  
Ari Fiani ◽  
Tri Pamungkas ◽  
Keyword(s):  
Survival Rate ◽  
Ex Situ Conservation ◽  
Block Design ◽  
Tree Height ◽  
Ex Situ ◽  
Average Height ◽  
Average Survival ◽  
Randomized Complete Block Design ◽  
Average Survival Rate ◽  
Number Of Branches

Ex-situ conservation plot of kayu merah (Pterocarpus indicus Willd) has been established in Gunungkidul in2016. The purpose of this study was to observe the early growth of kayu merah in the plot at 2 years old. The plot was laid-out in randomized complete block design consisting of 68 families, 4 tree-plot and 5 blocks with spacing of 3 m × 3 m. Genetic materials of kayu merah were collected from 3 populations namely Timor, Flores and Seram. Measurement was conducted in survival rate, tree diameter, tree height and number of branches. The result showed that the average survival rate of family was high (≥80%). Based on the populations, the survival rate of Timor, Flores and Seram were around 95%, 96% and 96.5% respectively. The average height, diameter and number of branches were 275 cm, 2.79 cm and 1.66, respectively. There were significant differences for height, diameter and number of branches among the tested families. In general, family ranking varied among the measured traits. Correlation between the traits varied among the populations. The Seram population showed the top family ranking for all the traits. It indicated that characterization in ex-situ conservation plot using genetic materials collected from the three populations was important for further conservation program of kayu merah.

scholarly journals The soft-release of captive-born Kaiser’s Mountain Newt Neurergus kaiseri (Amphibia: Caudata) into a highland stream, western Iran

2019 ◽  
Vol 11 (10) ◽  
pp. 14259-14267
Author(s):  
Tayebe Salehi ◽  
Vahid Akmali ◽  
Mozafar Sharifi
Keyword(s):  
Survival Rate ◽  
Animal Species ◽  
Captive Breeding ◽  
Overall Survival Rate ◽  
International Union ◽  
Western Iran ◽  
Average Survival ◽  
Mesh Bags ◽  
Two Stages ◽  
Average Survival Rate

Captive breeding and reintroduction programs are important conservation tools and are used for increasing the number of plant and animal species worldwide.  The endemic Kaiser’s Mountain Newt Neurergus kaiseri is listed as Vulnerable on the Red List by the International Union for Conservation of Nature (IUCN) and is amended to Appendix I of the Convention of International Trade on Endangered Species (CITES).  In the present study, in order to learn about the survival ability of captive-born newts of N. kaiseri, we conducted a trial translocation of 15 two-year-old captive-born N. kaiseri into the highland stream in Sartakht Village, western Iran.  The survival rate of these newts were determined in two stages, involving early acclimatization in mesh bags and direct release in a highland brook.  In 12 surveys to the translocation site, a total of 86 individuals were identified during spring and summer.  The average survival rate during the acclimatizing phase was 98 ± 0.04 %, while an average survival rate of 12 ± 0.04 % was obtained when the newts were released in the brook.  Applying an average diurnal detection probability obtained for the Yellow Spotted Mountain Newt Neurergus derjugini, the overall survival rate in September when newts began the autumn withdrawal was 13%.  These findings demonstrate that captive-born N. kaiseri released into the wild in controlled conditions can survive during spring and summer and provide information for future reintroduction plan of this species.

scholarly journals Vegetative Propagation of Balanites aegyptiaca (L.) Del. by Air Layering under Sahelian Climate in Niger

2019 ◽  
pp. 1-10
Author(s):  
Maman Kamal Abdou Habou ◽  
Habou Rabiou ◽  
Laouali Abdou ◽  
Boubacar Moussa Mamoudou ◽  
Ismaël Bio Yandou` ◽  
...  
Keyword(s):  
Survival Rate ◽  
Vegetative Propagation ◽  
Diameter Class ◽  
Balanites Aegyptiaca ◽  
Fruit Species ◽  
Average Survival ◽  
Significant Difference ◽  
Class 1 ◽  
Average Survival Rate ◽  
Diameter Classes

Balanites aegyptiaca (L.) Del. is a fruit species from the Sahelian and Sudano-sahelian zones, highly appreciated by the population. It provides a source of income for the rural population and its various parts are used for human and animal food, handicrafts and traditional medicine. However, the lack of data on propagation techniques of the species is a significant limitation to its domestication. This study aims to evaluate the vegetative propagation capacity of Balanites aegyptiaca by air layering. The trials were conducted in the Arboretum of Sahara Sahel Foods in Zinder, Niger. The layers were placed on orthotropic branches. The variables selected were the diameter class (1-2 cm, 2-3 cm and 3-4 cm) and the substrates (sand+manure, sand+sawdust and sand). A total of 116 layers were made. The results show that 93.1% of the layers have taken root two months after realization. The diameter classes and the three substrates have no significant influence on the number of roots. In contrast, root length varied significantly with substrates (P = 0.000) and branch diameter classes (P = 0.031). As for the diameter of the newly formed roots, a significant difference was observed between the diameter classes and the substrates have no significant effect on this parameter. One month after weaning of layers, an average survival rate of 68.5% was obtained. The seedlings of the diameter class 2-3 cm have the highest survival rate (83.1%). These results suggest that it is possible to produce Balanites aegyptiaca plants by air layering, and could contribute to the development of strategies adapted to its domestication.

scholarly journals  Winter survival of Phytophthora alni subsp. alni in aerial tissues of black alder        

2012 ◽  
Vol 58 (No. 7) ◽  
pp. 328-336 ◽  
Author(s):  
K. Černý ◽  
V. Strnadová
Keyword(s):  
Survival Rate ◽  
Winter Survival ◽  
Mild Winter ◽  
Black Alder ◽  
Average Temperature ◽  
Average Survival ◽  
Pathogen Survival ◽  
The Difference ◽  
Average Survival Rate ◽  
Potential Climate Change

The winter survival of the invasive pathogen Phytophthora alni subsp. alni in black alder stems was studied in the bankside alder stand of the Moravsk&aacute; Dyje River in southern Bohemia after two very different winter seasons: cold in 2008/2009, with the average temperature of &ndash;1.96&deg;C, and extremely mild in 2006/2007, with the average temperature of 2.54&deg;C. The difference in these two winters resembles the expected potential climate change in Central Europe in this century. After the cold winter of 2008/2009, the pathogen survived in only 13.91% of the samples, with the average survival rate of 2.70%. The pathogen survived the mild winter much better and was successfully isolated from 86.09% of the samples, with the average survival rate of 25.52%. Moreover, the total thickness of the covering tissues (outer + inner bark) and exposure to the most heated southwestern quadrant of stem girth positively affected the pathogen survival. Winter freezing seems to be an important environmental factor regulating the pathogen survival in alder stems and disease severity. &nbsp; &nbsp;

scholarly journals Microrna-142 Deficiency Promotes Chronic Myeloid Leukemia (CML) Transformation from Chronic Phase (CP) to Blast Crisis (BC)

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 4-4
Author(s):  
Bin Amber Zhang ◽  
Dandan Zhao ◽  
Huafeng Wang ◽  
Chen Liang ◽  
Le Xuan Truong Nguyen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chronic Myeloid Leukemia ◽  
Cell Growth ◽  
Myeloid Leukemia ◽  
Blast Crisis ◽  
Chronic Phase ◽  
Differentially Expressed ◽  
Prolonged Survival ◽  
Research Support ◽  
Cml Model

Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm resulting from the BCR-ABL1 fusion gene that encodes a constitutively activated tyrosine kinase (TK). Although TK inhibitors (TKIs) induce disease remission and prolonged survival in CML patients, a subset are resistant and progress from chronic phase (CP) to blast crisis (BC) with poor prognosis. Understanding the molecular mechanisms of transformation from CP to BC is necessary in the development of effective treatments. Here, we used the inducible SCLtTA/BCR-ABL transgenic CP CML model to study the molecular mechanism of disease evolution. Upon tetracycline withdrawal to induce BCR-ABL expression, both the SCLtTA/BCR-ABL homozygous (homo, i.e., SCLtTA+/+BCR-ABL+/+, hereafter called BCR-ABL) and heterozygous (het, i.e., SCLtTA+/-BCR-ABL+/-) mice developed and died of CP CML without developing BC CML, implying that BCR-ABL dosage is insufficient to induce transformation. MicroRNA (miR)-142 is highly expressed in hematopoietic cells with a critical role in normal hematopoiesis. In miR-142 knockout (KO)(miR-142−/−) mice, hematopoietic stem and progenitor cells expanded with a decrease of hematopoietic output. Loss of miR-142 function has been reported in lymphoma, acute lymphocytic leukemia and acute myeloid leukemia. Of note, we also observed lower levels of miR-142 in CD34+CD38- cells from patients with BC CML versus (vs) patients with CP CML. Thus, we hypothesized that miR-142 insufficiency may promote CML transformation from CP to BC. To test our hypothesis, we generated miR-142 KO BCR-ABL (i.e., miR-142−/−BCR-ABL) mice and observed increasing leukemic blasts over time after BCR-ABL induction in the blood and bone marrow (BM), but not in miR-142 wt (miR-142+/+)BCR-ABL controls even when the latter became moribund. MiR-142−/−BCR-ABL mice had larger spleens and significantly shorter survival [median: 26 vs 54 days (d); p&lt;0.0001] than miR-142+/+BCR-ABL controls. Of note, while both homo (miR-142−/−) and het (miR-142+/−) miR-142 KO BCR-ABL mice eventually developed BC CML, the former had a significantly faster progression to BC and shorter survival (median: 26 vs 45 d; p=0.003) than the latter, suggesting miR-142 deficiency alone is sufficient to initiate BC transformation in the CP CML model in a dose-dependent manner. Importantly, all these features were recapitulated in congenic recipient mice transplanted with BM Lin-Sca-1+c-Kit+ cells (LSKs, 2000/mouse) from diseased miR-142−/−BCR-ABL mice, suggesting LSKs were enriched in leukemic stem cells and able to reproduce BC. Of note, in an RNA-seq analysis comparing LSKs from diseased miR-142−/−BCR-ABL (BC) and miR-142+/+ BCR-ABL(CP) mice, 504 genes were found differentially expressed. Gene set enrichment analysis (GSEA) showed only four pathways differentially expressed (upregulated); three [i.e., oxidative phosphorylation, glycolysis and adipogenesis] regulating cell metabolism and the fourth regulating protein secretion. Next, we developed a novel CpG-miR-142 mimic oligonucleotide, hereafter called CpG-M-miR-142, to restore miR-142 levels. Treatment with CpG-M-miR-142 (20mg/kg/day, iv, 4 weeks) on day 2 after BCR-ABL induction significantly prolonged survival of miR-142−/−BCR-ABL mice compared with CpG-scramble (SCR) (75% vs 33% survival rate at day 40 after BCR-ABL induction; median survival: not reached vs 25 d; p=0.03). Since we observed lower miR-142 levels in TKI-resistant vs TKI-sensitive CML patients (p=0.02), we selected LSKs from diseased miR-142−/−BCR-ABL and miR-142+/+BCR-ABL mice and exposed them to TKI nilotinib (NIL; 2µM) or vehicle for 72 hours to evaluate if downregulation of miR-142 was associated with TKI resistance. We observed lower apoptosis and higher cell growth in NIL-treated miR-142−/−BCR-ABL LSKs vs NIL-treated miR-142+/+BCR-ABL LSKs. The decreased sensitivity of miR-142−/−BCR-ABL LSKs to TKI was rescued by treatment with CpG-M-miR-142. CpG-M-miR-142 (2µM) plus NIL significantly increased apoptosis and reduced cell growth in miR-142−/−BCR-ABL LSKs compared with SCR+ NIL. We showed a key role of miR-142 deficiency in the transformation of CP CML to BC CML associated with deregulation of metabolic pathways. Restoring miR-142 expression in vivo with CpG-M-miR-142 significantly decreased the BC transformation rate, prolonged survival of miR-142−/−BCR-ABL mice and may increase sensitivity to TKIs. Disclosures Marcucci: Iaso Bio: Membership on an entity's Board of Directors or advisory committees; Abbvie: Speakers Bureau; Novartis: Speakers Bureau; Pfizer: Other: Research Support (Investigation Initiated Clinical Trial); Takeda: Other: Research Support (Investigation Initiated Clinical Trial); Merck: Other: Research Support (Investigation Initiated Clinical Trial).

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