Sample Size Determination Sample Clauses
The Sample Size Determination clause defines how the number of participants or units to be included in a study or trial is established. Typically, this clause outlines the statistical methods or criteria used to calculate the appropriate sample size, taking into account factors such as study objectives, expected effect size, and desired statistical power. By clearly specifying how sample size is determined, the clause ensures that the study is adequately powered to detect meaningful results, thereby enhancing the reliability and validity of the findings.
Sample Size Determination. In total, approximately 200 subjects will be randomized in a 1:1 ratio to receive 1 of the following study drugs: • Vibegron 75 mg (N = 100) • Placebo (N = 100) At most, 50% of randomized subjects (approximately 100 subjects total [50 per treatment arm]) will have IBS-M; and at least 50% of randomized subjects (approximately 100 subjects total [50 per treatment arm]) will have IBS-D, and the IBS-D subgroup will be used for the primary endpoint analysis. Assuming a total of 10% of subjects will discontinue prior to Week 12 (for any reason), there will be a minimum of approximately 90 evaluable IBS-D subjects (45 in the vibegron arm and 45 in the placebo arm) at the end of Week 12. The study has approximately 60% power to detect a between-group treatment difference of 20% in proportion of abdominal pain responders at a 2 -sided test at the α = 0.10 level assuming a responder rate of 51% versus 31% for vibegron and placebo, respectively. The assumptions were based on results from a solabegron study female subgroup analysis [▇▇▇▇▇▇▇▇, 2008].
Sample Size Determination. The primary objective of this study is to compare the effects of treatment for 3 years with A previous large long-term (3-year) study in COPD (FLIT78, ISOLDE) reported all-cause mortality rates of 16% with active treatment (FLIXOTIDE*) and 21% with * FLIXOTIDE is a Trade Mark of GlaxoSmithKline group of companies. placebo among all subjects randomised [Waterhouse, 1999], and 18% vs. 27% among subjects with FEV1 <60% predicted. Among subjects in this sub-group, the surviving proportions at annual intervals were as follows.
Sample Size Determination. In a previous *** study evaluating the effects of VI-0521, subjects treated with a *** had a mean (SD) weight loss of *** for subjects receiving *** treated subjects. If similar standard deviations are achieved in the present trial, the planned sample size of at least 250 subjects per treatment group should provide *** power to detect these differences.
Sample Size Determination. To demonstrate the efficacy of a combination therapy, the combination (phentermine and topiramate) must be superior to both of the individual components that comprise the combination and placebo, at ***. The projected sample size of this trial is determined by the anticipated mean difference between the *** and the ***. In a previously conducted VIVUS *** trial, *** had a ***, compared to ***. In this trial, the effect of the *** is roughly equal to ***. Assuming the weight reduction for ***, and the weight reduction for ***, then the estimated effect of *** would be ***. Similarly, the estimated effect for *** would be ***. The effect of the *** is estimated as ***. Therefore, the estimated sample size is based on detecting a mean difference of *** between the ***. The pooled standard deviation for percent change in body weight from this *** trial was approximately ***. With 100 subjects in each of the *** in this trial, the trial should have more than *** power to demonstrate that the *** is an effective combination.
Sample Size Determination. For the primary efficacy endpoint on change from baseline (worst pain experienced within 1 month of screening visit) to 6-month on VAS, two sample t-test was used to calculate the sample size using PASS 15 power analysis and sample size software (NCSS LLC, UT USA). The mean change was assumed to be the same, and standard deviation was assumed to be the same at 2.4 for both the LiquiBand FIX8® and AbsorbaTack™ for ▇▇▇▇ and TEP laparoscopic groin hernia (femoral and inguinal) repair. The non-inferiority margin was set to 0.9 (as supported by the following references; [21] [22]), alpha at 0.025, and the target statistical power at 80%. Under these assumptions, a total sample size of 226 subjects (113 per group) is required for the study. With an attrition rate of about 20%, a total of 284 subjects will be enrolled.
Sample Size Determination. The patients are recruited at diagnosis of LD SCLC. After completion of induction therapy, patients with CR or PR (fulfilling all inclusion / exclusion criteria) will be randomized. These two phases will be referred to as "registration phase" and "randomization phase".
Sample Size Determination. In previous studies in adults, VI-0521 mid-dose (PHEN/TPM 7.5 mg/46 mg) resulted in a placebo-subtracted BMI reduction of 2.4 units with a standard error approximately 0.16 units and a within treatment standard deviation of 2.9. A very conservative estimate of the treatment difference between the mid-dose and placebo would be 2 units of BMI which represents more than 2 standard errors below what was observed before. If we enroll 200 subjects (50 placebo, 50 mid-dose, and 100 top-dose), we will have at least 90% power to detect a statistically significant difference between the top-dose (PHEN/TPM 15 mg/92 mg) and the placebo because we could assume that the top-dose will have a higher effect size than the mid-dose. This calculation assumes that there will be an approximately 30% dropout rate. This sample size will also provide approximately 80% power to detect a statistically significant difference between the mid-dose and placebo.
Sample Size Determination. The sample sizes are based on a pragmatic approach to study patients with PNH who are treatment-naïve, and patients with PNH who have received C5 inhibition treatment with eculizumab. Based on the results from the PNH monotherapy Studies ACH471-100 and ACH471-103, and the PNH combination therapy Study ACH471-101, it is anticipated that 10 patients in the treatment naïve group and 10 patients in C5 inhibitor switch group will be adequate to demonstrate the effectiveness of ALXN2050 as monotherapy in treating patients with PNH. For the primary endpoint of change from baseline to Week 12 in Hgb, the group of 10 patients each in treatment naïve cohort and eculizumab switch cohort will provide 87% power to detect the mean increase from baseline of 2 g/dL, assuming standard deviation of 1.8 g/dL and two-sided 0.05 significance level. The patients who switch from danicopan monotherapy in Study ACH471-103 will provide additional efficacy and safety data for ALXN2050 monotherapy.
Sample Size Determination. Sample size calculation was performed using SAS® version 9.4 with the EXACT method. A sample size of approximately 40 patients is estimated for this cohort to provide assessment of clinical activity of the treatment based on ▇▇▇. The null hypothesis that the true response rate is ≤25% (H0: p ≤ 0.25) will be tested against a 1-sided alternative of ≥45% (Ha: p ≥ 0.45). If there are 15 or more responses observed among 40 treated patients, it will be concluded that the lower bound of 80% confidence interval excludes H0 and the null hypothesis will be rejected. With 40 patients treated, the cohort has 87% power to rule out a ≤25% ▇▇▇ (null hypothesis) when the true ▇▇▇ is 45% at the 10% type I error rate (1-sided). Enrollment will be stratified based on histology (epithelial vs carcinosarcoma). Enrollment of patients with carcinosarcoma will be limited to comprise approximately 10% of the cohort (ie, approximately 4 patients).
Sample Size Determination. With a total of 60 subjects (30 per group) and assuming a drop-out rate of no more than 20%,