Teratogenic Potential of FD&C RED NO. 3 When given by Gavage

1993 ◽  
Vol 9 (4) ◽  
pp. 605-616 ◽  
Author(s):  
T.F.X. Collins ◽  
T.N. Black ◽  
D.I. Ruggles
Keyword(s):  
Clinical Findings ◽  
Feed Consumption ◽  
Maternal Weight ◽  
Entire Treatment Period ◽  
Developmental Effects ◽  
Random Occurrence ◽  
Teratogenic Potential ◽  
Fetal Size ◽  
Dose Levels ◽  
Entire Treatment

FD&C Red No. 3 (erythrosine) is a commonly used food additive. As part of a series of studies on the potential fetal developmental effects of food colors, FD&C Red No. 3 was administered by gavage to pregnant Osborne-Mendel rats at daily dose levels of 15, 30, 100, 200, 400, or 800 mg/kg on days 0-19 of gestation. Control animals were given distilled water by gavage. On gestation day 20, the animals were euthanized and cesarean sections were performed. During the entire treatment period, feed consumption by the animals given 400 mg/kg doses was increased significantly; the increases in the animals given 30 or 800 mg/kg were of borderline significance. The only significant increase in maternal weight gain, on days 0-7 in the animals given 30 mg/kg, was considered a random occurrence. No dose-related changes were seen in maternal clinical findings, implantations, fetal viability, or fetal size (weight and length). No fetal terata were seen, and neither skeletal nor visceral development was affected. FD&C Red No. 3 was neither fetotoxic nor teratogenic at 800 mg/kg when given by gavage.

Developmental Toxicity of Orange B Given to Rats in Drinking Water

1995 ◽  
Vol 11 (4) ◽  
pp. 387-397 ◽  
Author(s):  
T.F.X. Collins ◽  
T.N. Black ◽  
D.I. Ruggles
Keyword(s):  
Drinking Water ◽  
Soft Tissue ◽  
Developmental Toxicity ◽  
Skeletal Development ◽  
Clinical Findings ◽  
Feed Consumption ◽  
Cesarean Sections ◽  
Maternal Weight ◽  
Fetal Size ◽  
Dose Levels

Orange B, a pyrazolone dye used to color frankfurter and sausage casings, was given in distilled drinking water to pregnant Osborne-Mendel rats throughout gestation. Assessed on the basis of fluid consumption, the dose levels of 0, 0.05, 0.1, 0.2, and 0.4% corresponded to daily Orange B consumption of 0, 67.5, 129.6, 266.6, and 532.3 mg/kg body weight, respectively. On gestation day 20, the females were euthanized and cesarean sections were performed. Throughout gestation, the treated animals consumed less fluid than did the controls, but the decreases were not dose-related. Feed consumption and maternal weight gain were not affected. No dose-related changes were seen in maternal clinical findings, implantations, fetal viability, or fetal size (weight and length). No compound-related effects were seen in sternebral development. Ossification of the interparietal bones was reduced at some dose levels, but the decreases were considered random because of absence of dose response. No dose-related effect was seen in the incidence of skeletal variations in fetuses or in the number of litters containing fetuses with skeletal variations. Skeletal development, as measured by the average number of ossified vertebrae, was similar in all groups. Soft-tissue development was not affected by dose levels of 0.05 to 0.2%. In animals treated with 0.4% Orange B, significant increases were seen in the incidence of hydroureters (severe and moderate), in the average numbers of fetuses with at least one and at least two soft-tissue variations per litter, and in the percentage of litters containing fetuses with at least two soft-tissue variations.

Developmental Toxicity Studies of Triethylene Glycol Monomethyl Ether Administered Orally to Rats and Rabbits

1996 ◽  
Vol 15 (5) ◽  
pp. 349-370 ◽  
Author(s):  
A. M. Hoberman ◽  
W. J. Krasavage ◽  
M. S. Christian ◽  
C. R. Stack
Keyword(s):  
Developmental Toxicity ◽  
Clinical Signs ◽  
Triethylene Glycol ◽  
Monomethyl Ether ◽  
Feed Consumption ◽  
Corpora Lutea ◽  
Maternal Body ◽  
Body Weights ◽  
Effect Level ◽  
Dose Levels

Triethylene glycol monomethyl ether (TGME) was administered orally via gavage stomach tube to mated Caesarean delivered (CD) rats and artificially inseminated New Zealand white rabbits on days 6–15 and 6–18 of gestation, respectively, at dose levels of 0, 625, 1,250, 2,500, or 5,000 mg/kg/day (rats) and 0, 250, 500, 1,000, or 1,500 mg/kg/day (rabbits). Clinical signs, maternal body weights, and feed consumption were monitored throughout the treatment period. The surviving rats and rabbits underwent Caesarean section on day 20 and day 29 of gestation, respectively. Fetuses were weighed, sexed, and examined externally and for soft tissue and skeletal alterations. In rats, the high dose significantly reduced maternal body weights, feed consumption, and gravid uterine weights. One dam in this group died on day 13 of gestation. Treatment-related clinical signs were seen only at the highest dose tested. Maternal feed consumption was significantly reduced at 5,000 and 2,500 mg/kg and slightly, but not significantly, reduced at 1,250 mg/kg. Doses as high as 5,000 mg/kg/day did not affect pregnancy rate, implantations, corpora lutea, live fetuses, or fetal sex ratios. Resorptions were significantly increased at 5,000 mg/kg, and fetal body weights were slightly reduced at 1,250 mg/kg and significantly reduced at 2,500 and 5,000 mg/kg. The incidences of malformations and external or internal soft tissue variations were not increased at doses as high as 5,000 mg/kg. Incidences of skeletal variations were increased at doses of 1,250 mg/kg and higher. The no-observable-effect level (NOEL) in rats, for both maternal and developmental toxicity, was 625 mg/kg, while 1,250 mg/kg was a no-observable-adverse-effect level (NOAEL) for maternal toxicity and may be very near the NOAEL for developmental toxicity. In rabbits, 1,500 mg/kg/day reduced maternal body weights and feed consumption and caused death, abortions, treatment-related clinical signs of toxicity, and reduced gravid uterine weights. One doe in the 1,000 mg/kg group died on day 18 of gestation, but no treatment-related signs were seen in the other animals in this group. Doses as high as 1,500 mg/kg did not significantly affect pregnancy rate, implantations, corpora lutea, resorptions, live fetuses, fetal body weights, or sex ratio. Incidences of malformations or external and internal variations were not increased at any of the dose levels. The only developmental toxicity seen in the rabbit was an increase in the incidence of two common skeletal variations, angulated hyoid alae and delayed ossification of the xiphoid process, at the highest dose tested. For maternal toxicity, the NOEL and NOAEL were 250 mg/kg and 500 mg/kg, respectively, and for developmental toxicity the NOEL and NOAEL were 1,000 mg/kg and 1,500 mg/kg, respectively. These studies indicate that TGME was not selectively toxic to developing rat or rabbit conceptuses.

scholarly journals NOVEL NANOCARRIERS FOR ETHNOPHARMACOLOGICAL FORMULATIONS

2018 ◽  
Vol 10 (4) ◽  
pp. 26
Author(s):  
V. Sivapriya ◽  
S. Ponnarmadha ◽  
N. Abdul Azeezand ◽  
V. Sudarshanadeepa
Keyword(s):  
Drug Delivery ◽  
Aqueous Solubility ◽  
Vital Role ◽  
Bioactive Constituents ◽  
Entire Treatment Period ◽  
Pharmaceutical Ingredients ◽  
Adequate Dose ◽  
Novel Drug ◽  
Bioactive Constituent ◽  
Entire Treatment

A numerous novel drug delivery system has been emerged by combining herbal medicine with nanotechnology to administer drugs encompassing the enhancement of compatibility and efficacy. The herbal phytoconstituents are compatible compared to the chemical active pharmaceutical ingredients (APIs). But the therapeutic consequence of the phytoconstituent is limited due to poor aqueous solubility. Therefore, the demand to develop a system which improves the solubility of the phytomedicine is mounting rapidly. Nanotechnology plays a vital role in increasing the solubility, enhancing the bioavailability and improving the drug specificity of bioactive constituents. Nanosystems such as liposomes, nanoparticles, phytosomes, ethosomes, nanoemulsions and solid lipid nanoparticles are used to deliver the bioactive constituent at an adequate dose to the site of action and during the entire treatment period. The current review discusses the various novel drug delivery systems which have been developed to attain better therapeutic response of the herbal drug.

Thalidomide-Dexamethasone vs. Melphalan-Prednisone as First Line Treatment and Thalidomide-Interferon vs. Interferon Maintenance Therapy in Elderly Patients with Multiple Myeloma.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 529-529 ◽  
Author(s):  
Heinz Ludwig ◽  
Elena Tothova ◽  
Roman Hajek ◽  
Johannes Drach ◽  
Zdenek Adam ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Maintenance Therapy ◽  
Early Treatment ◽  
Haematological Toxicity ◽  
Skin Toxicity ◽  
Entire Treatment Period ◽  
Best Response ◽  
Retrospective Comparison ◽  
Odd Cycles ◽  
Entire Treatment

Abstract Thalidomide-Dexamethasone (TD) is an active regimen both in patients (pts) with relapsing/refractory and in untreated pts with multiple myeloma (MM). Here we compare TD with standard Melphalan-Prednisone (MP) in previously untreated elderly pts with MM. 274 pts have been enrolled (median age: 72 yrs, stage I: 9 (3%), stage II: 84 (31%), stage III: 179 (65%). Pts were randomized to T 200mg/day and D 40mg, days 1–4 and 15–18 (on odd cycles) and days 1–4 (on even cycles) or M 0.25mg/kg days 1–4 and P2mg/kg days 1–4, q 4–6 weeks. T should be dosed up to 400mg/day, if feasible. Pts achieving response or SD were randomized to maintenance therapy either with T (≤200mg/day)-Interferon-a2b (IFN, 3Mega U, TIW) or IFN (3Mega U/TIW). Zoledronic acid (4mg) was administered monthly to all pts during the entire treatment period. Response is defined according Blade’s criteria, plus nCR defined as IF positive or >90%↓ in PP and VGPR defined as >75% ↓reduction in PP. 231 pts are evaluable per protocol. Best response to TD: CR (14%) nCR 17%, VGPR 17%, PR 21%, yielding an ORR (CR-PR) of 68%. Best response to MP: CR 7%, nCR 8%, VGPR 14%, PR 22%; ORR 51% (ORR in TD vs. MP p=.0044). Time to response and time to best response were shorter in the TD (6, 16 weeks, respectively) compared to the MP group (16, 25 weeks, respectively; p<.001, p<.002, respectively).There was a tendency for more early treatment discontinuations in the TD arm (15 vs. 11, p=.416) and a higher mortality during the first treatment year (31 vs. 17, p=.026). Pts treated with MP showed a tendency for longer EFS (median: 43 vs. 25mos; p<.07) and had sign. longer OS compared to those on TD (median: 58 vs. 45mos;p=.029). A retrospective comparison of pts ≤ aged 72 showed no difference in OS (median: 57.9 vs. 50 mos, p<.186) but OS was longer in pts >72 yrs treated with MP (median: 46.5.9 vs. 25.4, p<.0625). Maintenance treatment in the 108 pts randomized to either T-IFN, or IFN only, did not result in a sign. difference in OS (from start of maintenance: not reached vs. 41.1 mos, p<.95). Pts on MP had a higher incidence of G 3–4 leucopenia (14% vs. 3%; p< .0001), while for thrombocytopenia only a tendency for a higher frequency was noted. Pts on TD had more G 2–3 neuropathy (28% vs. 10%, p<.001), constipation (30% vs. 10%, p<.001), psychological toxicity (18% vs. 6%, p<.0006), and a tendency for a higher rate of skin toxicity (9% vs. 5%, p=.069), and infections (23% vs. 16%, p<.12) compared to those on MP. The cumulative incidence of DVTs was 15% in pts on TD and 6% in those on MP (p=.089). In conclusion, TD treatment resulted in sign. higher rate of CR/nCR and ORR, a sign. shorter time to response and to best response. Pts on TD had similar EFS but sign. shorter OS. This was particularly true in pts aged >72 years but not in those aged ≤72 who showed similar OS with TD and MP. Pts on TD had more neuropathy, DVT, psychological toxicity, and a higher rate of early treatment discontinuations, while haematological toxicity was higher in pts treated with MP.

Developmental exposure to fenproporex: reproductive and morphological evaluation

2005 ◽  
Vol 24 (8) ◽  
pp. 397-402 ◽  
Author(s):  
C Q Moreira ◽  
M JSS Faria ◽  
J E Baroneza ◽  
R J Oliveira ◽  
E G Moreira
Keyword(s):  
Gravid Uterus ◽  
Maternal Weight ◽  
Developmental Exposure ◽  
Morphological Evaluation ◽  
Anorectic Drugs ◽  
Significant Difference ◽  
Uterine Growth ◽  
Teratogenic Potential ◽  
C 30 ◽  
Cervical Ribs

This study was designed to evaluate the maternal toxicity and teratogenicity of fenproporex, one of the most widelyused anorectic drugs in many countries, including Brazil. Three periods of exposure were evaluated: (a) 30 days before mating; (b) from gestational day (GD) 0 to 14; and (c) 30 days before mating and during pregnancy, until GD 14. Female mice from experimental groups received, by gavage, 15 mg/kg of fenproporex. Treatment with fenproporex increased ambulation of dams in the open field test and did not influence the mobility in the forcedswimming test. There was no significant difference in maternal weight gain between the controls and fenproporex-treated groups, although fenproporex treatment reduced the gravid uterus weight. No significant difference was observed in postimplantation loss, fetal viability and sex ratio. In addition, this compound did not impair intra-uterine growth. The reduction in the number of implantations in the groups receiving fenproporex indicates that this drug may have an adverse effect on implantation. Fenproporex treatment also increased the number of fetuses presenting small kidneys and cervical ribs. The present results indicate that fenproporex, in the dose and exposure periods tested, appears to exhibit a low maternal toxicity and teratogenic potential in mice.

scholarly journals Surgery in Hemophilia

1977 ◽  
Author(s):  
Seymour Zimbler
Keyword(s):  
New England ◽  
Medical Center ◽  
Factor Ix ◽  
Entire Treatment Period ◽  
Tunnel Syndrome ◽  
Total Knee ◽  
Factor Ix Deficiency ◽  
University Of Massachusetts ◽  
The University ◽  
Entire Treatment

The result of followup evaluation on the treatment of 110 Hemophiliacs followed within a comprehensive Hemophilia Clinic through the Tufts New England Medical Center and Memorial Hospital in Worcester, as well as the University of Massachusetts in Worcester, Massachusetts. A larger total of 300 Hemophiliac patients of all types have been followed.40 patients or more have undergone surgical procedures on various joints during the past 7 years. The results of these operations have been reviewed and guidelines are presented regarding their treatment. Breakdown of operative procedures include synovectomy of the knee 7, total knee arthroplasty, 5. Also included are arthrodeses of the knee, ankle, and subtalar joints as well as the elbow. Soft tissue procedures such as heel cord lengthening, decompression of carpal tunnel syndrome, excision of pseudo tumor are also included. Arthroplasty and synovectomy require 3 weeks or more of active treatment with levels of Factor VIII maintained at 50% for the entire treatment period. Those individuals treated by arthrodesis or simpler procedures require infusions for 10 days to 2 weeks. Factor IX deficiency patients require levels of 30-50% for their entire treatment program.

Safety of front-line bevacizumab (BEV) combined with weekly paclitaxel (wPAC) and q3w carboplatin (C) for ovarian cancer (OC): Results from OCTAVIA.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 5017-5017 ◽  
Author(s):  
Antonio Gonzalez-Martin ◽  
Laurence Gladieff ◽  
Bengt Tholander ◽  
Daniel Stroyakovsky ◽  
Martin Eric Gore ◽  
...  
Keyword(s):  
Treatment Period ◽  
Clear Cell ◽  
Single Agent ◽  
Figo Stage ◽  
Stage I ◽  
Phase Iii ◽  
Front Line ◽  
Entire Treatment Period ◽  
Grade 3 ◽  
Entire Treatment

5017^ Background: In two randomized phase III trials in OC (GOG218 and ICON7), front-line BEV + q3w PAC + q3w C followed by BEV alone significantly improved progression-free survival (PFS) vs chemotherapy (CT) alone. In the Japanese NOVEL trial, wPAC + q3w C was more effective than q3w PAC + C, but toxicity limited CT delivery. The single-arm OCTAVIA study evaluated front-line BEV + wPAC + q3w C. Methods: Patients (pts) received 6–8 cycles of BEV (7.5 mg/kg, d1) + wPAC (80 mg/m2 d1, 8, 15) + C (AUC6, d1) iv q3w, with BEV q3w continued alone for a total of up to 17 cycles (1 y) as front-line therapy for newly diagnosed OC (FIGO stage I–IIa [grade 3/clear cell] or stage IIb–IV [any grade]). The trial was designed to recruit a pt population similar to that enrolled in ICON7. The primary endpoint was PFS. Secondary endpoints included response rate, duration of response, overall survival, biological progression-free interval, and safety. Previously we reported safety findings from the concurrent CT phase. Here we present final safety results from the entire treatment period. Results: Between Jun 2009 and Jun 2010, 189 eligible pts were enrolled. Baseline characteristics: median age 55 y (range 24–79 y); ECOG 0 74%; FIGO stage I/II/III/IV 10%/10%/63%/17%; serous/clear cell/mixed 65%/6%/6%; 71% optimally debulked. Pts received a median of 6 CT cycles (range 1–8) and 17 BEV cycles (range 0–18). Of the 168 pts who received single-agent BEV, 135 completed 1 y of therapy. In the entire treatment period, BEV was discontinued for adverse events (AEs) in 12% and disease progression (PD) in 10%. The most common grade ≥3 hematologic AEs were neutropenia (60%), anemia (8%), and thrombocytopenia (7%). The incidences of grade ≥3 AEs of special interest for BEV were: hypertension 4.2% (grade 2/3/4: 9.0%/3.2%/1.1%); thromboembolic events 6.3% (grade 3/4: 3.7%/2.6%); bleeding 0.5% (grade 3), wound-healing complications 0.5% (grade 3), and GI perforation 0.5% (grade 4). There was no grade ≥3 proteinuria or fistula/abscess. At the time of data cut-off, 9 pts had died, all from PD. Conclusions: BEV combined with wPAC is feasible and well tolerated. BEV AEs were no more frequent with wPAC in OCTAVIA than with q3w PAC in ICON7.

Evaluation of teratogenic potential of cyfluthrin, a synthetic pyrethroid in Swiss albino mice

2010 ◽  
Vol 26 (2) ◽  
pp. 105-111 ◽  
Author(s):  
Farah Syed ◽  
Inderpal Soni ◽  
PJ John ◽  
Pradeep Bhatnagar
Keyword(s):  
Cranial Sutures ◽  
Average Weight ◽  
Maternal Weight Gain ◽  
Maternal Weight ◽  
Swiss Albino Mice ◽  
Maturation Phase ◽  
Subcutaneous Edema ◽  
Characteristic Symptom ◽  
Teratogenic Potential ◽  
Albino Mice

A toxicity study was planned to assess the teratogenic potential of cyfluthrin that is widely used as a household insecticide to control mosquitoes, flies and cockroaches. Pregnant Swiss albino mice of one group were orally administered two doses of the pesticide (16 mg/kg and 32 mg/kg body weight) daily during the organogenetic phase (days 5—14) of gestation. The second group received the same two doses daily during the maturation phase (days 14—18) of gestation. The animals receiving the higher dose exhibited burrowing behaviour, which is a characteristic symptom of pyrethroid poisoning. The autopsies were performed on the 18th day of gestation and routine teratological observations were made. No external malformations occurred in any of the fetus. The higher dose significantly reduced the number of live fetuses, litter size and increased the resorption of embryos when administered during organogenesis, while exposure to the pesticide during the maturation phase did not significantly affect the reproductive parameters. During both the phases, the higher dose reduced the maternal weight gain and the average weight of the fetuses. The fetal anomalies observed were reduced ossification of skull bones, widened cranial sutures, short or absent ribs, hydrocephaly of the ventricles, microphthalmia, anophthalmia, pulmonary edema and subcutaneous edema.

scholarly journals Interaction OF Dithane M-45 (MANCOZEB) and Lead Acetate during a teratogenicity test In rats

2000 ◽  
Vol 48 (1) ◽  
pp. 113-124 ◽  
Author(s):  
Andrea Kárpáti ◽  
I. Takács ◽  
L. Várnagy ◽  
P. Budai ◽  
E. Molnár
Keyword(s):  
Lead Acetate ◽  
Treated Group ◽  
Teratogenic Effect ◽  
Fetal Mortality ◽  
Control Group ◽  
Maternal Weight ◽  
Teratogenic Effects ◽  
Combined Administration ◽  
Group A ◽  
Dose Levels

The teratogenic effects of lead acetate (Trial 1) and the possible teratogenic effect of this compound administered in combination with a fungicide containing 80% mancozeb (Trial 2) were studied in rats. The test substances were administered by gavage on Days 6-15 of gestation. In Trial 1, five groups were treated with lead acetate administered at doses of 0.1, 0.5, 1.0, 10.0 and 1000.0 mg/kg body weight (bwkg), respectively. In Trial 2, lead acetate was applied at doses of 0.1, 10.0 and 1000.0 mg/bwkg, respectively. In the latter case the dose of the pesticide was 750 mg/bwkg in all treated groups. Lead acetate was not teratogenic after a single administration. Combined administration of lead acetate and mancozeb gave rise to the following toxic effects: average maternal weight decreased during pregnancy, the ratio of live fetuses decreased after the two lowest doses, and fetal mortality increased in the lowest and in the highest dose groups. The ratio of fetal resorption was higher in all the treated groups than in the control group. A significant decrease occurred in average fetal and placental weight in each treated group as compared to the control. Maternal toxicity was expressed in paralysis of the hindlimbs in the two lowest dose groups. Maternal mortality was between 16.7 and 23.3% at the three dose levels. Phocomelia and hernia cerebri occurred as characteristic fetal developmental anomalies in all the treated groups. It is concluded that the joint administration of lead acetate and a mancozeb-containing fungicide can cause maternal toxicity, embryotoxicity and characteristic teratogenic effects.

scholarly journals Clinical Impact of Enrollment of Clinical Trial in Multiple Myeloma; Single Center Experience

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5525-5525
Author(s):  
Seo-Yeon Ahn ◽  
Sung-Hoon Jung ◽  
Ga-Young Song ◽  
Deok-Hwan Yang ◽  
Jae-Sook Ahn ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Clinical Trials ◽  
Conflicts Of Interest ◽  
Entire Treatment Period ◽  
Entire Cohort ◽  
Single Center Experience ◽  
Significant Difference ◽  
National University ◽  
Entire Treatment

Purpose : Many clinical trials have been conducted to prove the efficiacy of the new agrent or treatment regimen in patients with multiple myeloma (MM), but there was no analysis of the effect of enrollment in clinical trials on survival in patients with MM. Therefore, we evaluate the survival outcome in patients with multiple myeloma who participated in clinical trial. Method: Retrospective data of 446 patients with newly diagnosed MM between January 2003 and December 2016 in Chonnam National University Hwasun Hospital were analyzed. Patients diagnosed with monoclonal gammopathy of undetermined significance, asymptomatic MM, and plasma cell leukemia were excluded. In addition, non-interventional study was not included as a clinical trial in this study. Results: The median overall survival (OS) for the entire cohort was 62.5 months (95%CI 52.4-72), and median OS has gradually improved (46.5 months in 2003-2008 vs. 64.9 months in 2009-2014 vs. not reached in 2015-2016, P = 0.007). A total of 197 patients (44.2%) participated in the clinical trial and 7.4% participated in more than two clinical trials during the entire treatment period. Participation rates in clinical trials were significantly higher in transplant-eligible patients than transplant-ineligible patients (55.7% vs. 34.8%, P <0.001). There was no significant difference in OS according to the enrollment of clinical trial in entire patients (62.9 months vs. 64.9 months, P = 0.265). In transplant-eligible patients, patients who participated clinical trial showed improved OS than patients who did not participate clinical trial (77.0 months vs. 52.1 months, P = 0.058). However, in transplant-ineligible patients, no survival benefits were showed from participation in clinical trial (50.3 months vs. 66.0 months, P = 0.811) Conclusion: This study showed survival benefit of enrollment of clinical trial in transplant-eligible patients. Further analysis is needed to analysis the effects of clinical trial in elderly patients. Figure Disclosures No relevant conflicts of interest to declare.

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