Study Visits. Upon signing of the informed consent, patients will enter a 1-4 week period of screening and prestudy training. Patients will be trained on self-administration of study drug and on recording of medication usage and local tolerance. After eligibility is assessed during the Screening period, a one week Pretreatment period is used to collect baseline data. Once enrolled, patients will return to their study center for safety and efficacy assessments at baseline (Day 1) and 1, 3, 6, 9, 12, and 18 months, and at any other time as warranted by safety, efficacy or compliance concerns. A final study visit is planned one month after the last dose of study drug. The study periods and number of clinic visits are summarized below:
Study Visits. At the End-of-Treatment Visit (Visit 9) for Study BA058-05-003, the possibility of participating in the Extension Study will be discussed with subjects randomized to Abaloparatide-SC/Placebo. This Extension Study will be comprised of 24 months of treatment with alendronate. In the month between Visit 9 and Visit 10 (between months 18 and 19 of Study BA058-05-003), the Investigator will consider the results of the assessments performed at Visit 9, including a local review of BMD, and determine if alendronate is appropriate for the subject, as part of this Extension Study. At the Follow-up (Visit 10 for Protocol BA058-05-003, Day 1 for Protocol BA058-05-005) subjects; who were randomized to Abaloparatide-SC/Placebo, who fulfill the inclusion/exclusion criteria (Section 4.1 and Section 4.2), and who have agreed to participate in the Extension Study; will sign the Informed Consent Form and be enrolled in the study. Subjects who have been determined by the Investigator to be candidates for alendronate therapy will receive open-label oral alendronate treatment at a total dose of 70 mg once per week for 24 months. Subjects will be instructed to take their first dose of alendronate for Study BA058-05-005 in the morning, within a week of their Day 1 visit. Following the initial six months of treatment in this study, subjects will enter the long-term observational phase of this study, during which subjects will continue to receive alendronate treatment for an additional 18 months. All subjects will have clinic visits for study related procedures at Day 1, Month 3, Month 6, Month 12, Month 18 and Month 24. For the purpose of this study one month is equal to 30 days.
Study Visits. At the End-of-Treatment Visit (Visit 9) for Study BA058-05-003, the possibility of participating in the Extension Study will be discussed with subjects randomized to BA058 80 µg/Placebo. This Extension Study will be comprised of standard-of-care osteoporosis management, including 24 months of treatment with alendronate. In the month between Visit 9 and Visit 10 (between months 18 and 19 of Study BA058-05-003), the Investigator will consider the results of the assessments performed at Visit 9, including a local review of BMD, and determine if alendronate is appropriate for the subject, as part of this Extension Study. At the Follow-up (Visit 10 for Protocol BA058-05-003, Day 1 for Protocol BA058-05-005) subjects; who were randomized to BA058 Injection 80 µg/Placebo, who fulfill the inclusion/exclusion criteria (Section 4.1 and Section 4.2), and who have agreed to participate in the Extension Study; will sign the Informed Consent Form and be enrolled in the study. Alendronate is the recommended osteoporosis treatment for this Extension Study. Subjects who have been determined by the Investigator to be candidates for alendronate therapy will receive open-label oral alendronate treatment at a total dose of 70 mg once per week for 24 months. Subjects will be instructed to take their first dose of alendronate for Study BA058-05-005 in the morning, on the day following their Day 1 visit. Following the initial six months of treatment in this study, subjects will enter the long-term observational phase of this study, during which subjects will continue to receive alendronate treatment for an additional 18 months. All subjects will have clinic visits for study related procedures at Day 1, Month 3, Month 6, Month 12, Month 18 and Month 24. For the purpose of this study one month is equal to 30 days. Exploratory statistical analyses will assess longer term safety, fracture incidence (including vertebral and non-vertebral fracture), and BMD change following treatment with alendronate for six months after the completion of a subject’s participation of 18 months in study BA058-05-003. The analyses performed at six months will be used as a follow-up to the 18 month fracture endpoint for Study BA058-05-003. At this time-point, subjects will be analyzed based on the randomization assignment in the BA058-05-003 study. Other analyses performed on the data in this study will be descriptive in nature.
Study Visits. The sending Party will pay the international return air fares of its visitors to the airport nearest to the first host institution in the programme, while the host Party will provide for the local costs of the visit (board, lodging and transport connected with the objects of the visit) in accordance with the Financial Annex to this agreement.
Study Visits. Usually for short periods of from one to three weeks, with the aim of visiting a number of laboratories in the host country for discussions and liaison, or for study visits.
Study Visits. 1. The aim of the study visits is to establish or enhance cooperation between researchers of both Parties in order to prepare and submit joint mobility project proposals to national or international funding bodies.
2. The exchange quota is one hundred and twenty (120) days per Party and year. The duration of study visit is not limited.
3. Eligible for study visits are: − on the Czech side, employees of the CAS institutes; − on the Slovak side, employees of the SAS institutes.
4. Selection process: − Requirements for the submission of study visit proposals and selection criteria shall be provided in national calls in compliance with internal regulations of the Parties. − Outgoing researchers shall identify and contact their counterparts from the partner country in order to agree on possible cooperation/study visits. Receiving researchers shall provide assistance to incoming researchers in order to enable/facilitate their access to other institutions (archives, libraries, universities etc.). Each year in January, the Parties shall exchange the overview of planned visits for the forthcoming year.
5. Implementation of approved study visits: − The sending Party shall submit the nomination of their researcher to the receiving Party at least ten (10) days prior to the proposed date of arrival. − The receiving Party shall review and approve the nomination and notify the sending Party of their decision at least five (5) days prior to the proposed date of arrival. − The sending Party shall provide the receiving Party with the travel itinerary of the outgoing researcher at least five (5) days prior to the date of arrival. − Restrictions on the realisation of study visits planned for the end of the fiscal year may apply.
Study Visits. 1. The aim of the study visits is to establish or enhance cooperation between researchers of both Parties in order to prepare and submit joint project proposals to national or international funding bodies.
2. The exchange quota is 14 days per Party and year. The duration of individual visits should not exceed 14 days.
3. Eligible for study visits are: − on the Czech side, researchers from the institutes of the CAS; − on the Bulgarian side, researchers from the institutes the BAS
4. Selection process: − Conditions for the submission of study visit proposals (including an invitation letter from the receiving institution) and selection criteria shall be provided in national calls in compliance with any internal regulations of the Parties. − Outgoing researchers shall identify and contact their counterparts from the partner country in order to agree on possible cooperation/study visits. Receiving researchers shall provide assistance to incoming researchers in order to enable/facilitate their access to other institutions (archives, libraries, universities etc.). − Each year in January, the Parties shall exchange the overview of planned visits for the forthcoming year.
5. Implementation of approved study visits: − The sending Party shall submit the nomination of their researcher to the receiving Party at least thirty (30) days prior to the proposed date of arrival. − The receiving Party shall review and approve the nomination and notify the sending Party of their decision at least fourteen (14) days prior to the proposed date of arrival. − The sending Party shall provide the receiving Party with the travel itinerary of the outgoing researcher at least ten (10) days prior to the date of arrival. − Restrictions on the realisation of study visits planned for the end of the fiscal year may apply.
Study Visits. 1. With a view to planning and organizing common cultural project the Parties shall organize study visits for experts in the field of culture employed in national cultural institutions.
2. All details pertaining to organization of study visits shall be agreed upon by relevant institutions from each Party, through working contacts.
Study Visits. For patients who completed Study RP103-03, study visits consist of: For patients who did not complete Study RP103-03, study visits consist of:
Study Visits. III.2.1. Biebrza
a. Land Parcel Information Systems (LPIS) and mark their coordinates using GPS devices, • localization of sensors on IGiK plots, which are used for validation and calibration satellite images, • discuss the work which were carried out and familiarize with the state of vegetation on the tested plots and typology of grasslands, • identification and comparative analysis of vegetation occurring on permanent grasslands in different grassland sites, especially taking into account the areas on which were located parcels included in the study.
