Placebo Sample Clauses

Placebo. Sponsor shall be responsible for the Manufacture and supply of placebo, comparator products and diagnostic products, in each case, as applicable and to the extent set forth in the applicable Study Plan; provided that, except as otherwise set forth in a Study Plan, Regeneron shall be responsible for the Manufacture and supply of placebo and diagnostic products for the Regeneron Product. The provisions of this Article 9 applicable to the supply of Product shall also apply to any such placebo or comparator product.
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Placebo. Participants randomised to Group 2 will receive a placebo injection of 0.9% saline (sourced by Xxxxxx Clinical Services) instead of MVA-NP+M1. Each vial of saline will only be used for a single participant.
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Placebo. Placebo vials matching the single-dose vials of IPP-201101 will be supplied by ImmuPharma. Each vial contains a white to off-white, amorphous powder as a lyophilized sterile formulation of mannitol (and acetic acid used for pH adjustment, if necessary). Before reconstitution, vials of placebo must be stored under refrigerated conditions (2° to 8° C [36° to 46° F]) in a secure place and protected from light. The study center will receive box(es) with up to 13 vials per box. Each vial will be labeled with a 4-digit treatment number and each box will contain placebo vials. Prior to administration, placebo should be reconstituted with 1.1 mL sterile water for injection (volume of injection of 1.1 mL). After reconstitution, the vial can be stored at controlled room temperature (20° to 25° C [68° to 77° F]) for up to 2 hours prior to administration and does not need to be protected from light. Patients randomly assigned to placebo will be administered placebo sc every 4 weeks for 48 weeks (a total of 13 doses will be administered). Method of Blinding: Patients will be randomly assigned to treatment through a qualified randomization service provider (eg, interactive response technology [IRT]). Patients and investigators will remain blinded to treatment assignment during the study. Study drug may not be administered by the same individual performing the SLEDAI- 2K, BILAG-2004, or PhGA. Study drug should be administered at each study visit after all study visit procedures and assessments have been completed.
Sample 1
Placebo. Formulation and specifications without the Active Principle, as specified in accordance with the specifications for Placebo attached hereto as Annex 2.
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Placebo. During this study there is a XX chance that you will receive a placebo. HIV Testing: Research procedures include testing for HIV. For studies that involve Whole Genome Sequencing (WGS): Make clear in the consent form that WGS will be included as a research procedure. Include a description of WGS such as; WGS is the sequencing of a human germline or somatic biospecimen with the intent to generate the complete DNA sequence of that biospecimen. After you complete the main part of the study...
Sample 1
Placebo. During this study you could receive placebo. This could lengthen the amount of time before you receive a treatment that may be effective. During this time you may experience worsening of your condition, including increased symptoms such as [XX]. The researchers will carefully monitor your condition. If your symptoms worsen and make you uncomfortable, you can withdraw from the study. Blood draw: Removing blood by a needle may cause temporary pain, bruising, bleeding, swelling, dizziness, and on rare instances fainting or infection. Exercise testing: The exercise test may cause muscle soreness, dizziness, or shortness of breath. In rare instances, exercise tests may cause chest pain, tightness, or a change in xxxxx xxxxx. Psychological discomforts: Some of the procedures may cause embarrassment or anxiety, or the questions the researchers ask you may be upsetting or make you uncomfortable. If you do not wish to answer a question, you can skip it and go to the next question. If you do not wish to participate you can stop. HIV testing: Being tested for HIV may make you feel nervous or anxious about the test results. A positive test indicates that you have been infected with the HIV virus, but no one knows for certain when, if ever, you will become sick with AIDS or a related condition. Receiving positive results may make you very upset. If other people learn about your positive test results, you may have trouble obtaining insurance or employment. To the extent permitted by law, the researchers will keep your test results confidential and will not release them to anyone without your written permission. If you test positive, California law requires health care providers and clinical laboratories to report the HIV test results with your personal identifying information to the local health department.
Sample 1
Placebo. Placebos (in appropriate studies) will be manufactured using the same excipients as the active tablets. Premix comprised of [**] and [**]. Additional inactive excipients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate are blended with [**] to match active tablets. All excipients used in the manufacture of the placebo tablets are of compendial grade and/or pharmaceutical quality. None of the excipients used in the manufacture of the drug product are novel or have animal or human origin. SCHEDULE 2.1 Overview Plan [**] Confidential SCHEDULE 10.2.2 Karyopharm Patent Coverage as of May 18, 2018 Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of 3 pages were omitted. [**]
Sample 1
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Placebo. Minimal dose Low dose Medium dose High dose 400mg every 4 weeks (Q4W) 800mg every 4 weeks (Q4W) 800mg every 2 weeks (Q2W) 1200mg every 2 weeks (Q2W) placebo Q2W 40.0% 51.5% 38.7% 45.5% 47.1% A statistically significant reduction of the dermatology life quality index, or DLQI, could be detected comparing the overall treatment arms with the placebo arm at week 16 (p=0.031). The median DLQI reduction at week 16 compared to pre-dose values was highest in the medium dose group (-5.5 points) when compared to the reduction in the placebo group (-1.5 points). There was a trend in the reduction of the overall AN count comparing the placebo group (median reduction of -3.0) and the low, medium and high dose group (-5.0, -5.0, and -4.5, respectively). IFX-1 was well tolerated. No difference could be detected in treatment emergent adverse events between placebo and treatment groups. Overall, 72% of placebo treated patients experienced a treatment emergent adverse event when compared to 66% of the combined IFX-1 treated groups. The most common treatment emergent adverse events were exacerbation of HS and nasopharyngitis. On July 18, 2019, we published a post-hoc analysis. This analysis showed multiple additional signals of efficacy for the IFX-1 high dose group compared to the placebo group within the initial phase of the SHINE study, which demonstrated significant reductions in all combined inflammatory lesions, on draining fistula and on the International Hidradenitis Suppurativa Severity Score 4, or IHS4, which also scores all inflammatory lesions and has been developed by an international expert group to score severity and track treatment response, although it has not been utilized in late stage clinical studies in HS. The IHS4 weights the most fluctuating lesions such as inflammatory nodules (1 point), less than abscesses (2 points) or draining fistulas (4 points). At week 16, there was a statistically significant reduction of draining fistulas, or DF, relative to baseline in the high dose IFX-1 group when compared to placebo (Figure 1 – relating to all patients with at least 1DF at baseline). Figure 1: DF reduction relative to baseline at week 16 (left: Mean, right: Median) in all patients with at least 1 draining fistula at baseline. For mean comparisons and the p-value of high dose versus placebo, an ANCOVA model adjusted for DF and Xxxxxx stage at baseline was calculated. The p-value for the median comparison of high dose versus placebo was based on the Wilcoxo...
Sample 1
Placebo. Provide matching placebo in sufficient quantities to supply MGH throughout the course of the Regimen Study. Packaging and labeling is the responsibility of MGH’s ALS Platform Trial Central Pharmacy vendor unless otherwise determined by the Company. Company shall ship drug directly to MGH’s ALS Platform Trial’s Central Pharmacy vendor for distribution to Study Sites in an appropriately temperature-controlled manner as specified by the Company.
Sample 1

Related to Placebo

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Hepatitis B Vaccine Where the Hospital identifies high risk areas where employees are exposed to Hepatitis B, the Hospital will provide, at no cost to the employees, a Hepatitis B vaccine.

  • Study Population Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).

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