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19OBE2109006 PROTOCOL V2.0 DATED 25 AUGUST 2020Page 1 of 122CLINICAL STUDY PROTOCOLProtocol Number:19OBE2109006EudraCT Number:201900241039Investigational Medicinal Product:Linzagolix (OBE2109)Study
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Gather all necessary information about your medical condition.
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Consult with your healthcare provider about linzagolix.
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For filling out with: ensure all personal information is accurate, including name, date of birth, and medical history.
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For filling out without: indicate the reasons for not using linzagolix, such as side effects or contraindications.
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Individuals diagnosed with uterine fibroids may need linzagolix with guidance from a healthcare provider.
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Patients who are seeking alternative treatments or cannot tolerate other medications may need linzagolix without.
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Linzagolix is an oral medication used primarily for the treatment of uterine fibroids. 'With' typically refers to the inclusion of adjunct therapies or hormones, whereas 'without' denotes the use of linzagolix as a standalone therapy.
Patients prescribed linzagolix may need to file documentation related to their treatment, while healthcare providers responsible for prescribing linzagolix must also complete and file necessary reports based on medication administration, with or without additional treatments.
Filling out paperwork for linzagolix involves providing patient information, dosage details, treatment duration, and relevant clinical data, whether the treatment is with adjunct therapies or standalone.
The purpose of linzagolix is to manage symptoms associated with uterine fibroids. 'With' refers to enhanced effectiveness when used with hormonal treatments, whereas 'without' indicates its use as a single-agent therapy.
The information that must be reported includes the patient's medical history, treatment type, dosage, administration route, and any side effects experienced during treatment with or without adjunct therapies.
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