SAMPLE SIZE CALCULATIONS Sample Clauses

SAMPLE SIZE CALCULATIONS. The American Psychological Association (APA; 1999) recommends a minimum sample size of 100 for a norm-referenced test. Further, for the development of regression-based norms for a psychological test which is short in length, with a small number of item scores, a minimum sample size of 100 is recommended (Oosterhuis, van der Ark, & Sijtsma, 2016). The previous unpublished norming study on the CVWMT-I (▇▇▇▇, 2016) had a sample size of N = 37. Based on these recommendations, the previous study and time constraints on the current study, the statistical tool, Quantifying the Uncertainty Attached to Normative Data (QUAND; ▇▇▇▇▇▇▇▇ & Garthwaite, 2008) was used to compare the 95% confidence intervals for a sample where N = 37 and N = 100. At the 50th percentile, a substantially narrower confidence interval was obtained for N = 100 (CI: 15 points) compared with N = 37 (CI: 25 points). Hence, this larger normative reference group was thought to represent a substantial improvement relative to the previous study. Based on this, the current study aimed to collect data for a sample of 100 participants for the norming study. The statistical package ICCSampleSize in R package version 1.0 (Rathbone, Shaw & ▇▇▇▇▇▇▇▇, 2015) was used to identify the sample size needed for test-retest and inter- rater reliability using intra-class correlation (ICC). To detect an effect size of 0.8, a sample size of 8 was found to give 80% power to detect effects of d = 0.8 where p = 0.05. A power analysis was conducted using G*Power (▇▇▇▇, Erdfelder, ▇▇▇▇, & ▇▇▇▇▇▇▇, 2007) to identify the sample size needed for parallel-form reliability. To detect a moderate effect size (0.6) a sample size of 45 for each group was found to give 80% power to detect effects of d = 0.6 or greater where p = 0.05. A power analysis was conducted to identify the sample size required for a construct validity analysis (i.e. comparing test performance on the CVWMT-I between the clinical and non-clinical groups). To detect a moderate effect size (0.5), guided by a preliminary study comparing scores on the ACT between controls and participants with severe TBI (Merkley, ▇▇▇▇▇▇, ▇▇▇▇▇▇ & Good, 2013), a sample size of 51 for each group was found to give 80% power to detect effects of d = 0.5 or greater, where p = 0.05. To detect a correlation of 0.6 for convergent validity, a sample size of 47 was found to give 80% power to detect effects of d = 0.6 or greater where p = 0.05, using G*Power (▇▇▇▇ et al., 2007). Table 1.1 belo...
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SAMPLE SIZE CALCULATIONS. The study will employ a Group Sequential Design (see Section 6.2.2.2) and is powered accordingly. In order to estimate the required numbers of deaths and randomised subjects required to provide at least 90% power for a true (absolute) difference of 4.3% compared to a placebo mortality rate of 17% at 3 years, the computer program PEST4 was used [MPS Research Unit, 2000]. If the true rates of survival among subjects randomised to treatment are 87.3% with SERETIDE and 83% with placebo, then the hazard ratio for treatment with SERETIDE compared to placebo is HR = 0.728. A total of up to 440 deaths in these two groups would provide 90% power to detect such a difference. Note that the possibility of satisfying the stopping rule at either of the planned interim analyses implies that the actual number of deaths in this study may be somewhat lower than this upper limit. For comparative purposes, using a fixed sample approach, the number of deaths required to provide this level of power is estimated as 418. In order to provide 440 deaths, it is estimated that approximately 1510 subjects must be randomised to either group. If the true mortality rates for SERETIDE and FLIXOTIDE are similar, then a similar number of deaths (440) among subjects treated with either FLIXOTIDE or placebo will provide 90% power to detect a true difference between FLIXOTIDE and placebo equivalent to a hazard ratio of 0.728 or less. The effect of Salmeterol on mortality is expected to be somewhat lower than for either SERETIDE or FLIXOTIDE. The primary objective of the study with regards the inclusion of the Salmeterol arm is therefore to provide as precise an estimate of the magnitude of the mortality effect as is practically achievable. Therefore, it is planned that approximately 1510 subjects will be randomised to each of the four treatment groups in order to provide up to 880 deaths. However, if the actual mortality rates are either lower or higher than anticipated, the actual numbers randomised may be amended compared to the current plan.
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SAMPLE SIZE CALCULATIONS. The sample size for this study is approximately 60 subjects. Each of the 3 cohorts will include 20 subjects (15 subjects receive AT-752 and 5 subjects receive placebo). ▇▇▇▇▇ Low et al (Low 2014) , the observed standard deviations for VLR, defined as mean change from baseline viral load on days 2, 3, and 4, ranged from 0.75 (N=26) to 1.07 (N=24). Taking into account that the VLR endpoint in that study was based on an average of 3 measurements and assuming that there is some correlation between measurements on days 2 through 4, we consider power to detect a true effect at a single time point using a one-sided
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SAMPLE SIZE CALCULATIONS. For Part 1, up to 48 subjects are planned: 8 subjects each in the mild (Cohort A), moderate (Cohort B), and severe (Cohort C) hepatic impairment cohorts and 8 to 24 healthy control subjects with normal hepatic function (Cohort D). For Part 2, at least 8 subjects with mild and moderate or moderate and severe hepatic impairment and up to 8 healthy control subjects with normal hepatic function are planned. The sample size was chosen for this study based on clinical and practical considerations and not on a formal statistical power calculation. The US Food and Drug Administration Guidance for Industry, Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling (DHHS 2003) was used as a guide to select the sample size, which is considered sufficient to adequately assess the safety and PK profiles of aramchol. In the event of early withdrawals or discontinuations, subjects may be replaced at the discretion of the investigator, and after consultation with the medical monitor and sponsor if the number of completers will be less than 6 subjects in any cohort.
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SAMPLE SIZE CALCULATIONS. The sample size (N = 36 [to allow at least 32 enrolled subjects to complete]) for this study is based on clinical and practical considerations and not on a formal statistical power calculation. The sample size is considered sufficient to effectively assess the PK and safety profiles of TPOXX.
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SAMPLE SIZE CALCULATIONS. Estimated rates of subsequent MRSA infection were based on the available literature. For patients without nasal colonization it was estimated that 2.5% of the population would develop a MRSA infection during follow-up while 10% of those with low nasal colonization (Ct > 24) and 30% of those with high (Ct ≤ 24) nasal colonization would subsequently develop an infection. Using a power of 80% and an alpha of 0.05, approximately 28 patients would be needed to show an effect when comparing high colonization to no colonization, 62 patients needed to compare high colonization to low colonization, and 150 patients comparing low colonization to no colonization. Approximately 50 patients per month are admitted to the AVAMC with MRSA nasal colonization. Of these patients, 30% have high nasal MRSA burden (≈ 15/month) and 70% have low nasal MRSA burden (≈ 35/month). Based on the above estimates and admission patterns at the AVAMC, it was estimated that four months worth of admission data would be needed to provide an adequate sample size. Descriptive statistics were used to compare the study population stratified by colonization status (negative, low burden, high burden). The purpose of this comparison was to identify potential factors that are associated with the exposure variable (colonization status). Differences in proportions of categorical variables (including demographic and clinical characteristics and co-morbidities) were tested using χ2. If expected cell counts were less than 5, ▇▇▇▇▇▇’▇ exact test was utilized. Continuous variables were analyzed with a one-way analysis of variance to compare means or two- sample T test. A p-value of ≤ 0.05 was considered significant. Unadjusted risk ratios were obtained for all covariates and the outcome in univariate analysis. Due to the limited published clinical data on nasal colonization burden, an exploratory analysis for potential interaction terms was performed. In this analysis, the study population was stratified on individual covariate levels and risk ratios for each level of the exposure variable (colonization status) were compared with the ▇▇▇▇▇▇▇-Day test. A p-value ≤ 0.10 was considered significant in addition to biologically plausible interaction terms. A multivariate logistic regression model was used to analyze the relationship between MRSA nasal colonization and subsequent infection. All covariates significant in univariate analysis (P < 0.10) and those considered clinically or epidemiologically relevant we...
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SAMPLE SIZE CALCULATIONS. Assuming a responder rate (microbiological cure) of 75% in the Solosec treatment group and a 40% placebo response rate and based on the use of a two-sided, two-sample comparison of proportions at the alpha=0.05 level of significance, a sample size of 100 patients (50 patients in each group) who meet the mITT criteria will provide approximately 95% power to demonstrate a statistically significant difference between Solosec and placebo. Assuming 70% of patients randomized in the study will meet the mITT criteria, approximately 144 patients will be enrolled into the study.
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Related to SAMPLE SIZE CALCULATIONS

  • Pro Forma Calculations (a) Notwithstanding anything to the contrary herein, financial ratios, tests and covenants, including the Leverage Ratio and the Fixed Charge Coverage Ratio shall be calculated in the manner prescribed by this Section 1.9. (b) For purposes of calculating any financial ratio, covenant or test, Specified Transactions (with any incurrence or repayment (excluding voluntary repayments) of any Debt in connection therewith to be subject to Section 1.9(c)) that have been made (i) during the applicable measurement period and (ii) subsequent to such period and prior to or simultaneously with the event for which the calculation of any such ratio is made shall be calculated on a pro forma basis assuming that all such Specified Transactions (and any increase or decrease in EBITDA and the component financial definitions used therein attributable to any Specified Transaction) had occurred on the first day of the applicable measurement period. If, since the beginning of any applicable period any Person that subsequently became a Subsidiary or was merged, amalgamated or consolidated with or into Borrower or any of its Subsidiaries since the beginning of such period shall have made any Specified Transaction that would have required adjustment pursuant to this Section 1.9, then such financial ratio or test shall be calculated to give pro forma effect thereto in accordance with this Section 1.9. (c) In the event that Borrower or any Subsidiary incurs (including by assumption or guarantees) or repays (including by redemption, repayment (other than voluntary repayments), retirement or extinguishment) any Debt included in the calculations of any financial ratio, covenant or test (in each case, other than Debt incurred or repaid under any revolving credit facility), (i) during the applicable period or (ii) subsequent to the end of the applicable period and prior to or simultaneously with the event for which the calculation of any such ratio is made, then such financial ratio or test shall be calculated giving pro forma effect to such incurrence or repayment of Debt, to the extent required, as if the same had occurred on the last day of the applicable period.

  • Certain Calculations Unless otherwise specified herein, the following provisions shall apply: (a) All calculations of interest with respect to the Mortgage Loans shall be made in accordance with the terms of the related Note and Mortgage. (b) For purposes of distribution of Yield Maintenance Charges pursuant to Section 4.01(d) of this Agreement on any Distribution Date, the Class of Non-Vertically Retained Principal Balance Certificates as to which the Non-Vertically Retained Percentage of any prepayment shall be deemed to be distributed shall be determined on the assumption that the portion of the Principal Distribution Amount paid to the Non-Vertically Retained Principal Balance Certificates on such Distribution Date in respect of principal shall consist first of the Non-Vertically Retained Percentage of scheduled payments included in the definition of Principal Distribution Amount and second of the Non-Vertically Retained Percentage of prepayments included in such definition. (c) Any Mortgage Loan payment is deemed to be received by the Trust Fund on the date such payment is actually received by the Master Servicer, the Special Servicer or the Certificate Administrator; provided, however, that for purposes of calculating distributions on the Certificates, Principal Prepayments with respect to any Mortgage Loan are deemed to be received on the date they are applied in accordance with Section 3.01(b) of this Agreement to reduce the outstanding principal balance of such Mortgage Loan on which interest accrues. (d) For purposes of calculating distributions on the Certificates and the Uncertificated VRR Interest and, in the absence of express provisions in the related Loan Documents (and/or, with respect to each Outside Serviced Mortgage Loan, the related Outside Servicing Agreement) to the contrary, for purposes of otherwise collecting amounts due under a Mortgage Loan, all amounts collected by or on behalf of the Trust in respect of any Mortgage Loan in the form of payments from the related Mortgagor, Liquidation Proceeds, Condemnation Proceeds or Insurance Proceeds (excluding, if applicable, in the case of each Serviced Loan Combination, any amounts payable to the holder(s) of the related Companion Loan(s) pursuant to the related Co-Lender Agreement) shall be deemed to be allocated in the following order of priority: (i) as a recovery of any unreimbursed Advances (including any Workout-Delayed Reimbursement Amount) with respect to the related Mortgage Loan, and unpaid interest at the Advance Rate on such Advances and, if applicable, unreimbursed and unpaid expenses of the Trust with respect to the related Mortgage Loan; (ii) as a recovery of Nonrecoverable Advances with respect to the related Mortgage Loan and any interest on those Nonrecoverable Advances at the Advance Rate, to the extent previously paid or reimbursed from principal collections on the Mortgage Pool (as described in the first proviso in the definition of “Aggregate Principal Distribution Amount”); (iii) to the extent not previously so allocated pursuant to clause (i) or (ii) above, as a recovery of accrued and unpaid interest on such Mortgage Loan (exclusive of Default Interest and Excess Interest) to the extent of the excess of (A) all unpaid interest (exclusive of Default Interest and Excess Interest) accrued on such Mortgage Loan at the related Mortgage Rate in effect from time to time through the end of the applicable Mortgage Loan interest accrual period, over (B) after taking into account any allocations pursuant to clause (v) below on earlier dates, the aggregate portion of the accrued and unpaid interest described in subclause (A) of this clause (iii) that either (1) was not advanced because of the reductions (if any) in the amount of related P&I Advances for such Mortgage Loan that have theretofore occurred under Section 4.06(a) of this Agreement in connection with related Appraisal Reduction Amounts or (2) accrued at the related Net Mortgage Rate on the portion of the Stated Principal Balance of such Mortgage Loan equal to any related Collateral Deficiency Amount in effect from time to time and as to which no P&I Advance was made; (iv) to the extent not previously so allocated pursuant to clause (i) or (ii) above, as a recovery of principal of such Mortgage Loan then due and owing, including by reason of acceleration of such Mortgage Loan following a default thereunder (or, if the Mortgage Loan has been liquidated, as a recovery of principal to the extent of its entire remaining unpaid principal balance); (v) as a recovery of accrued and unpaid interest on such Mortgage Loan (exclusive of Default Interest and Excess Interest) to the extent of the sum of (A) the cumulative amount of the reductions (if any) in the amount of related P&I Advances for such Mortgage Loan that have theretofore occurred under Section 4.06(a) of this Agreement in connection with related Appraisal Reduction Amounts, plus (B) any unpaid interest (exclusive of Default Interest and Excess Interest) that accrued at the related Net Mortgage Rate on the portion of the Stated Principal Balance of such Mortgage Loan equal to any related Collateral Deficiency Amount in effect from time to time and as to which no P&I Advance was made (to the extent that collections have not been allocated as recovery of such accrued and unpaid interest pursuant to this clause (v) on earlier dates); (vi) as a recovery of amounts to be currently allocated to the payment of, or escrowed for the future payment of, real estate taxes, assessments and insurance premiums and similar items relating to such Mortgage Loan; (vii) as a recovery of any other reserves to the extent then required to be held in escrow with respect to such Mortgage Loan; (viii) as a recovery of any Yield Maintenance Charge then due and owing under such Mortgage Loan; (ix) as a recovery of any late payment charges and Default Interest then due and owing under such Mortgage Loan; (x) as a recovery of any Assumption Fees, assumption application fees and Modification Fees then due and owing under such Mortgage Loan; (xi) as a recovery of any other amounts then due and owing under such Mortgage Loan other than remaining unpaid principal and other than, if applicable, accrued and unpaid Excess Interest (and, if both Consent Fees and Operating Advisor Consulting Fees are due and owing, first, allocated to Consent Fees and, then, allocated to Operating Advisor Consulting Fees); (xii) as a recovery of any remaining principal of such Mortgage Loan to the extent of its entire remaining unpaid principal balance; and (xiii) in the case of an ARD Mortgage Loan after the related Anticipated Repayment Date, as a recovery of any accrued but unpaid Excess Interest; provided that, to the extent required under the REMIC Provisions, payments or proceeds received (or receivable by exercise of the lender’s rights under the related Loan Documents) with respect to any partial release of a Mortgaged Property (including following a condemnation) at a time when the loan-to-value ratio of the related Mortgage Loan or Serviced Loan Combination, as applicable, exceeds 125%, or would exceed 125% following any partial release (based solely on the value of the real property and excluding personal property and going concern value, if any) must be collected and allocated to reduce the principal balance of the Mortgage Loan or the related Serviced Loan Combination in the manner permitted by the REMIC Provisions. (e) Collections by or on behalf of the Trust in respect of any REO Property (exclusive of amounts to be allocated to the payment of the costs of operating, managing, leasing, maintaining and disposing of such REO Property and, if applicable, in the case of each Serviced Loan Combination, exclusive of any amounts payable to the holder(s) of the related Companion Loan(s) pursuant to the related Co-Lender Agreement) shall be deemed to be allocated for purposes of calculating distributions on the Certificates and (subject to any related Co-Lender Agreement and/or Outside Servicing Agreement) for purposes of otherwise collecting amounts due under the Mortgage Loan in the following order of priority: (i) as a recovery of any unreimbursed Advances (including any Workout-Delayed Reimbursement Amount) with respect to the related REO Mortgage Loan and interest at the Advance Rate on all Advances and, if applicable, unreimbursed and unpaid expenses of the Trust with respect to the related REO Mortgage Loan; (ii) as a recovery of any Nonrecoverable Advances with respect to the related REO Mortgage Loan and any interest on those Nonrecoverable Advances at the Advance Rate, to the extent previously paid or reimbursed from principal collections on the Mortgage Loans (as described in the first proviso in the definition of “Aggregate Principal Distribution Amount”); (iii) to the extent not previously so allocated pursuant to clause (i) or (ii) above, as a recovery of accrued and unpaid interest on the related REO Mortgage Loan (exclusive of Default Interest and Excess Interest) to the extent of the excess of (A) all unpaid interest (exclusive of Default Interest and Excess Interest) accrued on such REO Mortgage Loan at the applicable Mortgage Rate in effect from time to time through the end of the applicable Mortgage Loan interest accrual period, over (B) after taking into account any allocations pursuant to clause (v) below or clause (v) of Section 1.02(d) above on earlier dates, the aggregate portion of the accrued and unpaid interest described in subclause (A) of this clause (iii) that either (1) was not advanced because of the reductions (if any) in the amount of related P&I Advances for the related REO Mortgage Loan that have theretofore occurred under Section 4.06(a) of this Agreement in connection with Appraisal Reduction Amounts or (2) accrued at the applicable Net Mortgage Rate on the portion of the Stated Principal Balance of such REO Mortgage Loan equal to any related Collateral Deficiency Amount in effect from time to time and as to which no P&I Advance was made; (iv) to the extent not previously so allocated pursuant to clause (i) or (ii) above, as a recovery of principal of the related REO Mortgage Loan to the extent of its entire unpaid principal balance; (v) as a recovery of accrued and unpaid interest on the related REO Mortgage Loan (exclusive of Default Interest and Excess Interest) to the extent of the sum of (A) the cumulative amount of the reductions (if any) in the amount of related P&I Advances for such REO Mortgage Loan that have theretofore occurred under Section 4.06(a) of this Agreement in connection with related Appraisal Reduction Amounts, plus (B) any unpaid interest (exclusive of Default Interest and Excess Interest) that accrued at the applicable Net Mortgage Rate on the portion of the Stated Principal Balance of such REO Mortgage Loan equal to any related Collateral Deficiency Amount in effect from time to time and as to which no P&I Advance was made (to the extent that collections have not theretofore been allocated as a recovery of such accrued and unpaid interest on earlier dates pursuant to this clause (v) or clause (v) of Section 1.02(d) above); (vi) as a recovery of any Yield Maintenance Charge then due and owing under the related REO Mortgage Loan; (vii) as a recovery of any late payment charges and Default Interest then due and owing under the related REO Mortgage Loan; (viii) as a recovery of any Assumption Fees, assumption application fees and Modification Fees then due and owing under the related REO Mortgage Loan; (ix) as a recovery of any other amounts then due and owing under the related REO Mortgage Loan other than, if applicable, accrued and unpaid Excess Interest (and, if both Consent Fees and Operating Advisor Consulting Fees are due and owing, first, allocated to Consent Fees and, then, allocated to Operating Advisor Consulting Fees); and (x) in the case of an ARD Mortgage Loan after the related Anticipated Repayment Date, as a recovery of any accrued but unpaid Excess Interest. (f) The applications of amounts received in respect of any Mortgage Loan pursuant to paragraph (d) of this Section 1.02 shall be determined by the Master Servicer in accordance with the Servicing Standard. The applications of amounts received in respect of any Mortgage Loan or any REO Property pursuant to paragraph (e) of this Section 1.02 shall be determined by the Special Servicer (unless such Mortgage Loan is, or such REO Property relates to, an Outside Serviced Mortgage Loan, in which case such applications shall be determined by the Master Servicer) in accordance with the Servicing Standard. (g) All net present value calculations and determinations made hereunder with respect to the Mortgage Loans, the Serviced Companion Loans or a Mortgaged Property or REO Property (including for purposes of the definition of “Servicing Standard”, and including, if and when applicable, with respect to an Outside Serviced Mortgage Loan or the related Mortgaged Property or any related REO Property) shall be made using the Calculation Rate. (h) For purposes of calculating Pass-Through Rates (where applicable) and distributions on, and allocations of applicable Realized Losses (where applicable) to, the Certificates and the Uncertificated VRR Interest, as well as for purposes of calculating the Servicing Fee, the Trustee/Certificate Administrator Fee, the Operating Advisor Fee and the Asset Representations Reviewer Ongoing Fee payable each month, each REO Property (including any REO Property with respect to an Outside Serviced Mortgage Loan held pursuant to an Outside Servicing Agreement) will be treated as if the related Mortgage Loan and any related Companion Loan(s) had remained outstanding and the related Loan Documents continued in full force and effect; and all references to “Mortgage Loan,” “Mortgage Loans” or “Mortgage Pool” (or any other capitalized terms of which such terms are a part) in this Agreement, when used in that context, will be deemed to also be references to or to also include, as the case may be, any related REO Mortgage Loan, and all references to “Companion Loan” or “Companion Loans” (or any other capitalized terms of which such terms are a part) in this Agreement, when used in that context, will be deemed to also be references to or to also include, as the case may be, any related REO Companion Loan. Each REO Loan will generally be deemed to have the same characteristics as its actual predecessor Mortgage Loan or Companion Loan, as applicable, including the same fixed Mortgage Rate (and, accordingly, the same Net Mortgage Rate) and the same unpaid principal balance and Stated Principal Balance. Amounts due on the predecessor Mortgage Loan or Companion Loan, as applicable, including any portion of those amounts payable or reimbursable to the Master Servicer, the Special Servicer, the Operating Advisor, the Asset Representations Reviewer, the Certificate Administrator or the Trustee, as applicable, will continue to be “due” in respect of the REO Loan; and amounts received in respect of the related REO Property, net of payments to be made, or reimbursements to the Master Servicer or Special Servicer for payments previously advanced, in connection with the operation and management of that property, generally will be applied by the Master Servicer as if received on the predecessor Mortgage Loan or Companion Loan, as applicable.

  • Proration of calculations If less than total program funding is subject to interest calculation procedures, the resulting interest liability calculations shall be prorated to 100% of program funding.

  • Interest Rates Payments and Calculations (a) Interest Rates. From the Effective Date, all Obligations charged to the Loan Account with respect to the Loans shall, subject to Section 2.5(c)(ii), bear interest payable in cash on the Outstanding Amount at a rate per annum equal to ABR plus the Applicable Margin and shall be payable in accordance with Section 2.5(c).

  • Financial Covenant Calculations The parties hereto acknowledge and agree that, for purposes of all calculations made in determining compliance for any applicable period with the financial covenants set forth in Section 6.7 and for purposes of determining the Applicable Margin, (i) after consummation of any Permitted Acquisition, (A) income statement items and other balance sheet items (whether positive or negative) attributable to the target acquired in such transaction shall be included in such calculations to the extent relating to such applicable period (including by adding any cost saving synergies associated with such Permitted Acquisition in a manner reasonably satisfactory to the Agent), subject to adjustments mutually acceptable to Borrowers and the Agent and (B) Indebtedness of a target which is retired in connection with a Permitted Acquisition shall be excluded from such calculations and deemed to have been retired as of the first day of such applicable period and (ii) after any Disposition permitted by Section 6.8), (A) income statement items, cash flow statement items and balance sheet items (whether positive or negative) attributable to the property or assets disposed of shall be excluded in such calculations to the extent relating to such applicable period, subject to adjustments mutually acceptable to Borrowers and the Agent and (B) Indebtedness that is repaid with the proceeds of such Disposition shall be excluded from such calculations and deemed to have been repaid as of the first day of such applicable period.