Number of Subjects. Up to one hundred (100) diagnostic patients will be enrolled and consented to participate in the study. These women will be enrolled from screening recall assigned BIRADS 0, patient complaint, and referral for second opinion. The final diagnostic workup outcome of these enrolled patients need to include: • At least thirty (30) pathology confirmed cancers • Various numbers of all BIRADS cases
Number of Subjects. All subjects who were randomized to the Abaloparatide-SC/Placebo arms in Study BA058-05-003, and who completed 18 months of treatment will be offered the opportunity to participate in this study. There will, therefore, be a potential maximum of 1,600 subjects eligible to be enrolled in this study.
Number of Subjects. Subjects who completed 18 months of treatment with either Abaloparatide-SC/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 Abaloparatide-SC/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.
Number of Subjects. All subjects who were randomized to the BA058 Injection 80 µg/Placebo arms in Study BA058-05-003, and who completed 18 months of treatment will be offered the opportunity to participate in this study. There will, therefore, be a potential maximum of 1,600 subjects eligible to be enrolled in this study.
Number of Subjects. Up to ***** patients may be enrolled in order to obtain ***** evaluable patients *****. To be considered evaluable, patients must either receive ***** and complete the ***** follow-up visit, or must have met the criteria for treatment failure. Patients who terminate the study prematurely for reasons other than treatment failure will be replaced. Main Inclusion Criteria: Patients who are at least ***** post first ***** for treatment of *****, who have received ***** from the time of ***** through the time of entry into the study, who have received an ***** for at least the ***** immediately prior to entry into the study, and who have undetectable ***** on two consecutive tests within the ***** screening period, are eligible for the study. Main Exclusion Criteria: Patients who are *****, or who have received other ***** are ineligible to participate. ***** Confidential material redacted and filed separately with the Commission. Test product, dose and mode of administration: HepeX-BÔ will be *****. · HepeX-BÔ ***** every ***** for ***** for all patients enrolled in the *****, with the possibility of an additional ***** for all patients enrolled in the ***** of the trial. All patients will be observed for ***** after completion of treatment. · HepeX-BÔ ***** every ***** for***** for all patients enrolled in the *****, with the possibility of an additional ***** for all patients enrolled in the ***** of the trial. All patients will be observed for ***** after completion of treatment. Reference therapy, dose and mode of administration: *****. · ***** for all patients enrolled in the *****, with the possibility of an additional ***** for all patients enrolled in the ***** of the trial. All patients will be observed for ***** after completion of treatment. Duration of treatment and observation: ***** for all patients enrolled in the *****, with the possibility of an additional ***** for all patients enrolled in the ***** phase of the trial. All patients will be observed for ***** after completion of treatment. Anti-viral assessments: ***** will be determined prior to and ***** following each *****. ***** results will be confirmed by repeat testing at least *****. ***** assessments: ***** will be determined immediately prior to each *****, at the end of each *****, ***** after the completion of each *****, and at***** after each *****. The ***** determined immediately prior to each ***** will be considered the *****. Safety assessments: Safety will be evaluated by ...
Number of Subjects. A total of 36 adult male or female subjects with presumed XXXX F2/F3 will be enrolled. Of the 36 subjects, 12 subjects will be enrolled in Cohort A to receive 75mg of CRV431, 6 subjects will be enrolled in Cohort B to receive the matching placebo of Cohort A, 12 subjects will be enrolled in Cohort C to receive 225mg of CRV431 and 6 subjects will be enrolled in Cohort D to receive the matching placebo of Cohort C.
Number of Subjects. For this part of study (PART B), the sample size calculation was based on the primary endpoint of progression free survival (PFS). A sample size is determined for each PIK3CA mutation status strata and irrespective of PIK3CA status (i.e. an overall sample size to compare treatment groups).
Number of Subjects. In total, approximately 200 subjects will be randomized in a 1:1 ratio (100 per treatment group). At most, 50% of randomized subjects (100 subjects total [50 per treatment arm]) will have IBS- M; and at least 50% of randomized subjects (100 subjects total [50 per treatment arm]) will have IBS-D. 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 per treatment group) at the end of Week 12. The sample size justification is provided in Section 9.2. Number of Sites: Approximately 40 sites in the United States.
Number of Subjects. Approximately 140 subjects with severe PPD will be randomized in a 1:1 ratio for approximately 70 subjects per treatment group. Additional subjects may be enrolled in order to ensure there are 130 evaluable subjects. Evaluable subjects are defined as those randomized subjects receiving study drug with valid baseline and at least 1 post-baseline HAM-D assessment.
Number of Subjects. In the event that CRO fails to meet the Protocol requirements on the number of Subjects to be recruited, Sponsor will be given the option to extend the recruitment period or to continue the Study with less Subjects.
