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Subject is willing to undergo a transvaginal ultrasound TVU to evaluate the uterus and ovaries at screening and at week 52 end of treatment. For subjects who are withdrawn from the study prior to completion, a TVU should be collected at the early discontinuation ED visit. This is not required for subjects who have had a partial supra-cervical or full hysterectomy. A biopsy with insufficient material for evaluation, or unevaluable material, is acceptable provided the endometrial thickness is no greater than 8 mm. Subject has documentation of a normal or not clinically ificant abnormal Papanicolaou Pap test or equivalent cervical cytology within the 12 months of screening or at screening. This is not required for subjects who have had a full hysterectomy.

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The seekinb in accordance with subsection 2sentence 1 no. The ban on entry and residence takes effect when the decision on the application for asylum assumes legal validity. These requirements are waived if the foreigner is unable to fulfil them on of a physical or affaris illness or disability. Section 9c Subsistence As a rule, foreigners have a fixed and regular income within the meaning of section 9a 2sentence 1, no.

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As a general rule, the ban on entry and residence is to be revoked if the conditions for issuing a residence title pursuant to Chapter 2 Part 5 are met. 25 biopsy with insufficient material for evaluation, or unevaluable material, is acceptable provided the endometrial thickness is no greater than 8 mm.

The supreme Land authority may permit exceptions to this rule in individual cases. In the case of cohabiting spouses, it suffices if one spouse if the fulfils the requirements of sentence 1, no.

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Periods of residence outside of the federal territory do not interrupt the period of residence pursuant to section 9a 2sentence 1, no. However, such periods do not interrupt the period of residence pursuant to section 9a 2sentence 1, no.

Section 9b Counting residence periods 1 The following periods are counted towards the necessary periods pursuant to section 9a 2sentence 1, no. The ban on entry and residence is to be limited in time when it is ordered in accordance with sentence 1.

If the condition is not met before the ban expires, the ban is automatically extended at the time it would expire under sentence 5. Subject has a history of a malignant tumor, except for non-metastatic basal cell carcinoma of the skin. The requirements of sentence 1, nos.

In all other cases, its length is not to exceed three years, as a general rule. Subject with Gilbert's syndrome with singlf total bilirubin TBL may be enrolled as long as hemolysis is ruled out i.

For subjects with a uterus: Subject has an unacceptable result from the TVU assessment at screening, i. Extending the temporary residence permit 1 Extending the temporary residence permit is subject to the same regulations as granting it.

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In these cases, subsection 4 sentences 4 and 5 applies accordingly. Section 12a Residence zeeking 1 In order to promote their lasting integration into the way of life in the Federal Republic of Germany, foreigners who have been granted asylum status, refugee status singgle the meaning of section 3 1 of the Asylum Act, subsidiary protection status within the meaning of section 4 1 of the Asylum Act or who have been granted a temporary residence permit for the first time pursuant to section 22, section 23 or section 25 3 are required to take up their habitual residence place of residence in that Land to which they have been allocated for the purposes of their asylum procedure or in the context of their admission process for a period of three years from the time such status or temporary residence was granted.

Where the grounds set out in sentence 2 cease to exist within a period of three months, the obligation to take up residence in accordance with sentence 1 continues to apply in the Land to which the foreigner has moved his or her residence. Periods of residence pursuant to section 9a 3no. Subsection 3 applies accordingly.

Periods of residence outside of the European Union are not counted. The clock begins to run when the foreigner leaves the country.

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Subject agrees not to participate in another interventional study while participating in the present study. Subject is unable or unwilling to complete the study procedures.

If the asylum application has been rejected in accordance with section 30 3nos. O Subjects with a medical history of hypertension who are well controlled may be enrolled.

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Section 9 2sentences 2 to 5 applies accordingly to sentence 1, nos. If a foreigner was or is obliged to attend an integration course pursuant to section 44a 1sentence 1, the temporary residence permit is to be extended for at most one year, as a general rule, if the foreigner has not successfully completed the integration course or has not yet furnished evidence that that he or she has achieved integration into the community and society by other means.

Please refer to this study by its ClinicalTrials. Section 9 1sentences 2 and 3 apply accordingly.

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In all other cases, the requirements of sentence 1, nos. Subject has active liver disease, jaundice, or elevated liver aminotransferases alanine aminotransferase [ALT] or aspartate aminotransferase [AST]elevated total or direct bilirubin, elevated international normalized ratio INRor elevated alkaline phosphatase ALP at screening.

In particular, geographic restrictions may be imposed on temporary residence permits in cases where there is public interest in expelling the foreigner pursuant to section 54 1 nos. Subsection 1 sentence 2, subsection 2 sentences 3 to 6, subsection 3 sentence 1 and subsection 4 sentences 1, 2 and 4 apply affsirs. The duration of former possession of a temporary residence permit or permanent settlement permit, if the foreigner possessed a permanent settlement permit when he or she left the federal territory, minus the duration of intermediate stays outside of the federal territory which led to expiry of the permanent settlement permit; a maximum of four years is counted.

In all other cases, the entry and residence ban is to be issued, as a general seking, together with the deportation warning or the deportation order under sibgle 58a, the condition precedent being the deportation or removal, or at the latest at the time of deportation or removal.

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Subject has a medical condition or chronic disease including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary [e. Subject has ly been enrolled in a clinical trial with fezolinetant. Section 9a EU long-term residence permit 1 Zeeking EU long-term residence permit is a permanent residence title. Subsection 5 applies accordingly to the subsequently immigrating dependants.

The supreme Land authority is responsible for deciding in the cases covered covered by subsections 5a and 5b. No ban on entry and residence is ordered where there are grounds for temporarily suspending deportation pursuant to section 60a for which the foreigner was not responsible. If a foreigner breaches the obligation to duly attend an integration sedking pursuant to section 44a 1sentence 1, this is to be taken into when deciding whether to extend the temporary residence permit.

The period may be extended in such cases, at the most, however, by the length of the original ban.