SELECTION OF STUDY POPULATION Sample Clauses

SELECTION OF STUDY POPULATION. Number of Subjects A sufficient number of otherwise healthy postmenopausal women aged 50 to 85 with osteoporosis will be screened so that 2400 eligible patients qualify for the study and are randomized. For the purposes of this study, osteoporosis is defined as a BMD that is 2.5 standard deviations or more below the norm of the adult female population. Postmenopausal women older than 65 who meet the fracture criteria but have a T-score < -2.0 and > -5.0 may be enrolled. Additionally, women older than 65 who do not meet the fracture criteria may also be enrolled if their T-score is < -3.0 and > -5.0. The specific inclusion and exclusion criteria for enrolling patients in this study are presented below in Sections 0 and 0, respectively. Exceptions to these criteria should occur infrequently and should be discussed in advance and approved by the Sponsor Medical Monitor. If the exception is agreed upon (rare) and a patient is allowed to participate, the Sponsor Medical Monitor will send confirmation to the study site acknowledging the exception. The confirmation form or letter must be kept with the study records. Minor variations from the normal range in clinical laboratory test results (hematology, chemistry, and urinalysis) are acceptable if they are determined to be not medically significant by the Investigator in that they do not compromise patient safety or the assessment of efficacy and are documented as such. Any unexpected clinically significant abnormality that would exclude the patient from participation in the study may be retested once. If the parameter is normal on retest, the patient may be included in the study.
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SELECTION OF STUDY POPULATION. 4.1 Number of Subjects Subjects who completed 18 months of treatment with either BA058 Injection 80 µg/Placebo in Study BA058-05-003 will be given the opportunity to participate in the Extension Study at all participating centers. Based on randomization to the BA058 Injection 80 µg/Placebo arms in Study BA058-05-003, up to 1,600 subjects may be entered into this study. The specific inclusion and exclusion criteria for enrolling subjects in this study are presented below in Sections 4.2 and 4.3, respectively. Exceptions to these criteria should occur infrequently and should be discussed in advance and approved by the Sponsor Medical Monitor.
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SELECTION OF STUDY POPULATION. Information Seminar & Baseline Visit Potential participants will be invited (through posters and ads, see appendix) to an information seminar with c. 10-20 attendees where the goals of the study as well as the means of its achievement are explained. Information is provided about health risks associated with smoking, as well as about possible alternative aids available for smoking cessation. The physiological effects of nicotine will be outlined, and an account given of the Swedish experience with snus including potential health risks associated with different types of smokeless tobacco products. The trial inclusion and exclusion criteria will be mentioned.
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SELECTION OF STUDY POPULATION. All patients will have a primary diagnosis of chronic HCV infection and will have been found to be non-responders to pegylated interferon-based therapy. Non-responders are defined as patients who are currently serum/plasma HCV-RNA positive and demonstrated less than a 2 log10 drop in their viral load at the end of 12 weeks of treatment with pegylated α interferon plus ribavirin or patients who did not achieve a 2 log10 decrease in viral load following 48 weeks of therapy with pegylated α interferon plus ribavirin with no evidence of a negative HCV-RNA at any time during the treatment period. The primary diagnosis includes proven chronic HCV infection at the time of screening for entry into the study with hepatitis C virus RNA positive by quantitative PCR prior to entry (≥ 104 IU/mL). · Treatment-naïve patients (to α interferon therapy) are not eligible for this study. · Patients who are unable to tolerate α interferon or ribavirin are not eligible for this study. Inclusion Criteria Patients must meet each of the following criteria to be considered eligible for entry into the study:
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Related to SELECTION OF STUDY POPULATION

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • 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.

  • Protocol No action to coerce or censor or penalize any negotiation participant shall be made or implied by any other member as a result of participation in the negotiation process.

  • 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.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Period for Review and Consideration of Agreement Executive understands he/she has been given a period of 21 days to review and consider this Agreement before signing it. Executive further understands he/she may use as much of the 21 day period as he/she wishes prior to signing.

  • Recognition of U.S. Special Resolution Regimes (i) In the event a Covered Party becomes subject to a proceeding under a U.S. Special Resolution Regime, the transfer of this Agreement (and any interest and obligation in or under, and any property securing, this Agreement) from such Covered Party will be effective to the same extent as the transfer would be effective under the U.S. Special Resolution Regime if this Agreement (and any interest and obligation in or under, and any property securing, this Agreement) were governed by the laws of the United States or a State of the United States.

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