Treatment Period Sample Clauses

Treatment Period. Subjects will enter into Study BA058-05-005 on Day 1, and Day 1 will also serve as Visit 10 (the Follow-up Visit) for Study BA058-05-003. The Informed Consent must be signed prior to undergoing any BA058-05-005 study related procedures, and may be signed at either Visit 9 or Visit 10 of Study BA058-05-003. Subjects who received BA058 Injection 80 µg/Placebo in Study BA058-05-003 will receive six months of open-label oral alendronate treatment as part of this study (BA058-05-005). Following the initial six months of treatment in this study, subjects will then enter the long-term observational phase of this study during which the subjects will continue to receive osteoporosis care for an additional 18 months. If determined by the Investigator to be appropriate, treatment will be by oral administration of alendronate at a total dose of 70 mg once per week. Subjects will be given a weekly diary card to record missed doses of medication including calcium and vitamin D. A total of six clinic visits are scheduled during the study (Day 1, Month 3, Month 6, Month 12, Month 18 and Month 24). Subjects will be instructed to take their first dose of study drug for Study BA058-05-005 in the morning on the day following their Day 1 visit (Day 2 of this study). Study subjects will continue calcium and vitamin D supplementation during this study as was administered during BA058-05-003 (Section 6.1). At Month 3, subjects will return to the clinic for medication resupply, subject diary review and questioning as to their use of concomitant medications and the occurrence of adverse events. At the Month 6 visit ECG, and safety labs will be performed. Vertebral fractures will be determined clinically and via protocol directed x-ray evaluation; non-vertebral fractures will be determined clinically. In addition, subjects will undergo a DXA of the hip and spine (and wrist, if the subject was enrolled in the wrist DXA sub-study in Study BA058-05-003), and have samples drawn for bone markers and anti-BA058 antibodies. Procedures are to be performed as described in Section 7.0, Appendix 14.1 and Appendix 14.2. At Months 12 and 18, subjects will return to the clinic for medication resupply, subject diary review and questioning as to their use of concomitant medications and occurrence of adverse events. At Month 24, subjects will return to the clinic and will undergo clinical and radiologic fracture assessments and have DXA of the hip and spine (and wrist, if the subject was enrolled in...
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Treatment Period. The Treatment Period starts on Day 1 and continues for 18 months (78 weeks). Patients are randomized to treatment on Day 1 and begin treatment the same day. A subset of 300 patients per group will have a wrist DXA scan, which will occur after randomization to study drug and can occur anytime up to 24 hours after the first injection. Those patients who are randomized to treatment with teriparatide will be trained with the teriparatide pen prior to the first injection on Day 1. A total of 7 clinic visits are scheduled during the Treatment Period (Visits 3-9); the final Treatment Period visit will be scheduled to occur one day after the last dose of study medication. Treatment will be daily, by self-injection. During the first 30 days Attachment 2, Attachment E-26 of treatment patients will record drug dose, site of injection and any local reactions in a patient diary card. Local tolerance will again be assessed during a second 30-day period. This second diary will be provided to the patient either at the Month [9] (Visit 7) or will be forwarded later by mail, as appropriate, for completion by the patient during the 30 days of treatment in Month [11] of treatment. The diary will be collected and reviewed with the patient for treatment compliance and adverse events at the Month [1] (Visit 4) and Month [12] (Visit 8) visits. The patient will also maintain a diary throughout the study to summarize all study drug administration on a weekly basis. Study patients will continue Calcium and Vitamin D supplementation during the Treatment Period. Safety will be assessed at each study visit during the Treatment Period. Efficacy assessments will include one evaluation by x-ray after 18 months of treatment (End-of-Treatment, Visit 9) and evaluations of BMD by DXA after [6], [12] and [18] months of treatment (Visits 6, 8 and 9). Serum markers of bone metabolism, BA058 antibody and BA058 serum levels will also be measured during the Treatment Period. Additionally, a subset of patients treated with BA058 80 µg or Placebo (up to [100] per group to obtain [75] evaluable biopsies per treatment group) will consent and have a bone biopsy performed between Visit 8 and the End-of-Treatment visit (Visit 9). A further subset of 100 patients per treatment group (BA058 80 µg, Placebo and teriparatide) will undergo a renal CT scan at End-of-Treatment (Visit 9). Procedures are to be performed according to the Schedule of Visits and Procedures (Appendix 14.1). Patients who discontinue fro...
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Treatment Period. 6.3.1 Status of Subjects Inpatient o Outpatient ý Either o
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Treatment Period. ‌ The treatment period is split into two phases: initial treatment and subsequent treatment. Initial treatment consists of six 21-day cycles where subjects receive the following per cycle: • A single dose of cisplatin or carboplatin (Day 1) • A continuous infusion of 5-FU (Days 1–4) • Three doses of cetuximab (Days 1, 8 and 15) • Two doses of IP (Days 8 and 15) Cycles 7+ consist of 28-day cycles where subjects receive the following per cycle: • Four weekly doses of cetuximab (Days 1, 8, 15, and 22) • Two doses of IP (Days 8 and 22) Treatment continues until the subject has PD. Upon independent confirmation of radiographic disease progression and completion of treatment, subjects will complete the End of Treatment visit (§6.3) and begin long-term follow-up.
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Treatment Period. Subjects will receive treatment with CRV431 or matching placebo from Day 1 to Day 28. Study visit days that include treatment administration occur on Days 1, 2, 7, 14, and 28. Visit windows will be allowed and are as follows: Day 7 and Day 14, the visit window is ± 1 day and Day 28 the visit window is + 2 days. If the study visit for Day 28 is extended, the subject must continue taking study drug until the visit is completed. Whole blood samples will be collected pre-dose and through Day 42 or early termination for safety and PK assessments as shown in Table 3 and Table 6, respectively. AEs will be collected as described in Section 11.4.
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Treatment Period. 6.2.1 Randomization (Visit 2) Subjects eligible for treatment will be randomized and study drug dispensed at Visit 2. Activities at randomization are: · Obtain study-specific written informed consent; · Collect urine sample for pregnancy test (females of childbearing potential only) and perform pregnancy test; · Obtain blood sample for laboratory testing (biomarkers); · Perform complete physical examination, including neurological examination and auscultation for heart sounds (may be performed between Visits 1 and 2 after results from Visit 1 indicate subject may be eligible to participate); *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. · Obtain written informed consent for *** procedures and perform *** scan ***. *** scans may be performed between Visit 1 and Visit 2, after results from Visit 1 indicate subject may be eligible to participate; · Perform 12-lead electrocardiogram (may be performed between Visits 1 and 2 after results from Visit 1 indicate subject may be eligible to participate); · Assess adverse events (including eye symptoms), if any; · Obtain xxxxx xxxxx; · Obtain weight and waist circumference measurements; · Assess changes in concomitant medications; · Administer *** for *** and ***; · Evaluate randomization criteria (Section 4.3); · If subject is eligible, contact IVRS and obtain subject study medication identification; · Obtain 5 mL serum sample to be retained for possible use for scientific exploratory testing; · Complete 24 hour dietary recall, distribute LEARN® materials and perform lifestyle counseling; · Dispense study medication *** from the assigned titration kit and provide instructions for proper use; · Schedule the next study visit in 2 weeks (± 2 days).
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Treatment Period. NI-0501 will be administered for 8 weeks as induction treatment of HLH. The treatment period will be divided in 2 separate periods: Treatment Period 1 and 2 (please refer to Figure 1). NI-0501 treatment can be shortened, although not less than 4 weeks, if patient’s condition and donor availability allow an earlier HSCT. Based on the current knowledge, no wash-out period is required between the last administration of NI- 0501 and the start of conditioning. In the event that an appropriate donor has not been identified by Week 8 or in case of the need to delay the schedule of HSCT for reasons unrelated to the administration of NI-0501, NI-0501 treatment can be continued beyond this time upon the request of the Investigator, provided a favourable benefit/risk has been established for that patient.
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Treatment Period. 2 (Weeks 3 to 8) Treatment period 2 includes the next infusions that will be performed twice a week, no closer together than 3 days. The safety and efficacy monitoring/assessment visits should occur every 6 days in Treatment Period 2, with an allowed time-window of ± 48 hours in order to be able to combine these visits with NI-0501 infusions. In case a dose modification is deemed necessary, the required clinical and laboratory data must be recorded/reported. If patients are no longer hospitalized, they must return to the sites to receive their NI-0501 infusions and to perform the planned assessments as per protocol. Patients in out-patient status must remain at the site for 8 hours following each NI-0501 infusion.
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Related to Treatment Period

  • Payment Period Whenever a payment under this Agreement specifies a payment period with reference to a number of days (e.g., “payment shall be made within forty (40) days following the date of termination), the actual date of payment within the specified period shall be within the sole discretion of the Company.

  • Measurement Period (b) In this Agreement, unless the contrary intention appears, a reference to:

  • Sales During Pre-Settlement Period Notwithstanding anything herein to the contrary, if at any time on or after the time of execution of this Agreement by the Company and an applicable Purchaser, through, and including the time immediately prior to the Closing (the “Pre-Settlement Period”), such Purchaser sells to any Person all, or any portion, of any shares of Common Stock to be issued hereunder to such Purchaser at the Closing (collectively, the “Pre-Settlement Shares”), such Purchaser shall, automatically hereunder (without any additional required actions by such Purchaser or the Company), be deemed to be unconditionally bound to purchase, and the Company shall be deemed unconditionally bound to sell, such Pre-Settlement Shares to such Purchaser at the Closing; provided, that the Company shall not be required to deliver any Pre-Settlement Shares to such Purchaser prior to the Company’s receipt of the purchase price of such Pre-Settlement Shares hereunder; and provided further that the Company hereby acknowledges and agrees that the forgoing shall not constitute a representation or covenant by such Purchaser as to whether or not during the Pre-Settlement Period such Purchaser shall sell any shares of Common Stock to any Person and that any such decision to sell any shares of Common Stock by such Purchaser shall solely be made at the time such Purchaser elects to effect any such sale, if any.

  • Evaluation Period Customer’s right to use the Services on a Trial Basis are time-limited and will terminate immediately upon the earlier of (i) the trial end date as specified in an Order Form or other document executed by the parties regarding such trial, or (ii) the start date of when Customer purchases a right to use such Services on a non-Trial Basis, or (iii) the date when QuoVadis terminates Customer’s right to use the Services on a Trial Basis (which QuoVadis may do at any time in its sole discretion). Customer must cease using the Services on a Trial Basis upon any such termination.

  • Distribution Compliance Period The Purchaser agrees not to resell, pledge or transfer any Purchased Shares within the United States or to any U.S. Person, as each of those terms is defined in Regulation S, during the 40 days following the Closing Date.

  • Reference Period As of any date of determination, the period of four (4) consecutive fiscal quarters of the Borrower and its Subsidiaries ending on such date, or if such date is not a fiscal quarter end date, the period of four (4) consecutive fiscal quarters most recently ended (in each case treated as a single accounting period).

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  • Facility Termination Date Any outstanding Loans and all other unpaid Obligations (other than contingent indemnity obligations) shall be paid in full by the Borrower on the Facility Termination Date. Notwithstanding the termination of this Agreement on the Facility Termination Date, until all of the Obligations (other than contingent indemnity obligations) shall have been fully paid and satisfied and all financing arrangements among the Borrower and the Lenders hereunder and under the other Loan Documents shall have been terminated, all of the rights and remedies under this Agreement and the other Loan Documents shall survive.

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