Pretreatment Period Sample Clauses

Pretreatment Period. During the Pretreatment Period, one visit (Visit 2) is scheduled. Patients will have baseline evaluations performed as outlined in the Schedule of Visits and Procedures (Appendix 14.1). Patients will undergo baseline efficacy labs. This study visit is to be scheduled within 7 days prior to the anticipated first day of treatment to allow confirmation of clinical laboratory test results and continued eligibility. Patients who have experienced a serious adverse event during the Pretreatment Period will be terminated from the study. Patients will undergo training on self-injection with the BA058 pen injector device in anticipation of treatment assignment. Teriparatide is a marketed treatment; therefore, if the patient is subsequently randomized to teriparatide, training will be done with the teriparatide pen after randomization but before the first injection on Day 1 (Visit 3). In addition, patients will be provided with daily Calcium (500—1000 mg) and Vitamin D (400—800 IU) supplementation, or a dose to be determined by Investigator and agreed upon by the Sponsor Medical Monitor, according to the patient’s need, which will be continued until the end of the Treatment Period; it will be recommended to patients that they continue these supplements through the Follow-up Period. Patients will be instructed to take the supplements during the evening with or without food or as otherwise instructed by the Investigator. Only the daily doses of Calcium and Vitamin D identified in the study protocol and determined by the Investigator may be taken during the study. Any patient unable to take the preparation of Calcium and Vitamin D supplied may be recommended a different preparation of Calcium and Vitamin D by the Investigator as long as the same daily dose of both Calcium and Vitamin D is administered. On completion of the Pretreatment period, eligible patients will enter the Treatment Period.
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Pretreatment Period 
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Related to Pretreatment Period

  • Meal Period Employees shall receive a meal period which shall commence no less than two (2) hours nor more than five (5) hours from the beginning of the employee's regular shift or when the employee is called in to work on their regular day off. The meal period shall be no less than one-half (½) hour nor more than one (1) hour in duration and shall be without compensation. Should an employee be required to work in excess of five (5) continuous hours from the commencement of their regular shift without being provided a meal period, the employee shall be compensated two (2) times the employee's straight-time hourly rate of pay for the time worked during their normal meal period and be afforded a meal period at the first available opportunity during working hours without compensation.

  • 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.

  • Maintenance Period During the Maintenance Period the Developer shall at its own expense maintain repair and otherwise keep the Works in good working order and repair to the reasonable satisfaction of xxx Xxxxxxxxxx unless xxx Xxxxxxxxxx shall declare that any required maintenance and/or repair is an emergency in which case the Developer shall carry out the said maintenance and/or repair immediately

  • No-­‐Activation Period Registry Operator shall not activate any names in the DNS zone for the Registry TLD (except for "NIC") until at least 120 calendar days after the effective date of this agreement. Registry Operator may allocate names (subject to subsection 6.2 below) during this period only if Registry Operator causes registrants to be clearly informed of the inability to activate names until the No-­‐Activation Period ends.

  • TREE TRIMMING Grantee or its designee shall have the authority to trim trees on public property at its own expense as may be necessary to protect its wires and facilities.

  • INTERIM MAINTENANCE PERIOD During the interim maintenance period between obtaining of the completion certificate of such Project and formation and operationalization of the Association the Promoter shall through itself or through a facility management company to run, operate, manage and maintain the Common Areas. The Promoter shall endeavour that the committee responsible for the maintenance and operation of the Common Areas will be required to provide manpower for maintaining the Common Areas, wherever required, and to collect maintenance charges and also guest charges and the user charges for the utilities being provided on “pay by use” basis, if any. The maintenance and management of Common Areas by the committee will primarily include but not limited to maintenance of water works, common electrical installations, DG Sets, landscaping, driveways, parking areas, lobbies, lifts and staircases, AMC’s etc. It will also include safety and security of the Project such as fire detection and protection and management of general security control of the Project. The Rules/ Bye Laws to regulate the use and maintenance of the Common Areas shall during the interim maintenance period shall be framed by the Promoter with such restrictions as may be necessary for proper maintenance and all the Allottees are bound to follow the same. After the Common Areas of the Project are handed over to the Association, the Association may adopt the Rules and the Bye laws framed by the Promoter, with or without amendments, as may be deemed necessary by the Association.

  • Xxxxx Period After payment of the first Dues, the Subscriber is entitled to a grace period of 30 days for the payment of any Dues due. During this grace period, the Agreement will remain in force. However, the Subscriber will be liable for payment of Dues accruing during the period the Agreement continues in force.

  • week period If an employee fails to return at the end of the family care or medical leave, the CSU may require repayment of insurance premiums paid during the unpaid portion of the leave. The CSU shall not require repayment of premiums if the employee's failure to return is due to his/her serious health condition or due to circumstances beyond the employee's control.

  • Cooling Off Period You may terminate this Contract with immediate effect at any time within the period of 14 days after the date this Contract is entered into without incurring any liability to DFMC.

  • Clean-Up Period (a) Notwithstanding anything to the contrary set forth herein or in any other Loan Document, during the Clean-Up Period, the occurrence of any breach of a representation, covenant or an Event of Default (other than an Event of Default set out in Section 9.1(a)) will be deemed not to be a breach of a representation or warranty or a breach of a covenant or an Event of Default, as the case may be, if it would have been (if it were not for this provision) a breach of representation or warranty or a breach of a covenant or an Event of Default only by reason of circumstances relating exclusively to, with respect to any Permitted Acquisition or other Permitted Clean-Up Investment (or the subsidiaries of such target), the target of such Permitted Acquisition or Permitted Clean-Up Investment, and provided that such breach or Event of Default: (i) is capable of being remedied within the Clean-Up Period and the Loan Parties are taking appropriate steps to remedy such breach or Event of Default; (ii) does not have and is not reasonably likely to have a Material Adverse Effect; and (iii) was not procured by or approved by Holdings or the Borrowers. (b) Notwithstanding Section 9.6(a), if the relevant circumstances are continuing on or after the expiry of the Clean-Up Period, there shall be a breach of representation or warranty, breach of covenant or Event of Default, as the case may be, notwithstanding the above (and without prejudice to the rights and remedies of the Agents and the Lenders). (c) For the avoidance of doubt, if any breach of representation or warranty, breach of covenant or Event of Default shall be deemed to not exist due to Section 9.6(a) during the Clean-Up Period, then such breach of representation or warranty, breach of covenant or Event of Default shall be deemed not to exist for purposes of Section 5.2 for so long as (but in no event later than the end of the Clean-Up Period) such breach of representation or warranty, breach of covenant or Event of Default shall be deemed not to exist due to the provisions of Section 9.6(a).

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