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    Summary
    EudraCT Number:2017-000145-40
    Sponsor's Protocol Code Number:versión2.febrero2017
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-07-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-000145-40
    A.3Full title of the trial
    Use of acupuncture for the reduction of hospital admissions in the induction of labor due to chronologically prolonged gestation.
    ACUPUNT STUDY
    Uso de acupuntura para la reducción de ingresos hospitalarios en la inducción al parto por gestación cronológicamente prolongada.
    ESTUDIO ACUPUNT
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of acupuncture for the reduction of hospital admissions in the induction of labor due to chronologically prolonged gestation.
    ACUPUNT STUDY
    Uso de acupuntura para la reducción de ingresos hospitalarios en la inducción al parto por gestación cronológicamente prolongada.
    ESTUDIO ACUPUNT
    A.3.2Name or abbreviated title of the trial where available
    Use of acupuncture in the induction labor
    Uso de la acupuntura en la inducción al parto
    A.4.1Sponsor's protocol code numberversión2.febrero2017
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsormontserrat zamora brito
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportagupunt acupuncture
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinic hospital of Barcelone
    B.5.2Functional name of contact pointFetal Medicine Barcelone
    B.5.3 Address:
    B.5.3.1Street AddressSabino arana 38
    B.5.3.2Town/ citybarcelone
    B.5.3.3Post code08028
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934487496
    B.5.6E-mailmontsezb@hotmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Acupuncture ES14/169797 Directive 93/42/EEC ES / MAD 200839 Principio activo: agujas acupuntura. Agujas de aceroinoxidable estériles.ISO7153-1para material quirúrgico.Adjunto etiquetado español y ficha técnica .
    D.2.1.1.2Name of the Marketing Authorisation holderAGU punt
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameacupunture
    D.3.2Product code ES14/16797
    D.3.4Pharmaceutical form Cutaneous stick
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAgujas
    D.3.9.1CAS number agujas
    D.3.9.2Current sponsor codeagujas
    D.3.9.3Other descriptive nameagujas
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This Clinical Trial will evaluate the efficacy and safety of acupuncture to promote labor in pregnant women who need an induction at birth and thus be able to give answers to all these women who are increasingly seeking these therapies, such as acupuncture, pregnancy and Childbirth together with usual medical practice.
    Este ensayo clínico evaluará la eficacia y la seguridad de la acupuntura para promover el trabajo de parto en mujeres embarazadas que necesitan una inducción al nacer y así poder dar respuestas a todas estas mujeres que buscan cada vez más estas terapias como la acupuntura, Práctica médica habitual.
    E.1.1.1Medical condition in easily understood language
    This Clinical Trial will evaluate the efficacy and safety of acupuncture to promote labor in pregnant women who need an induction labor.
    Este ensayo clínico evaluará la eficacia y la seguridad de la acupuntura para promover el parto en mujeres embarazadas que necesitan una inducción al parto
    E.1.1.2Therapeutic area Health Care [N] - Health Services Administration [N04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effectiveness of acupuncture for the reduction of the rate of programmed admissions in medicalized inductions in low- and medium-risk pregnant women between 40-42 w
    Evaluar la eficacia de la acupuntura para la reducción de la tasa de ingresos programados en inducciones médicas en mujeres embarazadas de bajo y medio riesgo entre 40-42 gestación
    E.2.2Secondary objectives of the trial
    Determine the time from the start of treatment to the beginning of labor
    * Know if there are differences in the obstetric conditions during treatment, at admission, and during periods of dilation and expulsion with respect to the control group.

    * To know if there are differences in the neonatal outcomes, the side effects to the treatment and the possible maternal complications between the women of both groups.

    * Identify if there are differences in alterations in uterine dynamics, risk of loss of fetal wellbeing and use of betamimetic drugs in women of both groups

    * Know if women in the control group use oxytocin more frequently and at higher doses than those in the experimental group. As well as treatment doses for drug induction at delivery.

    * Evaluate if there are differences in the number of cesarean sections of both groups. To know the degree of satisfaction of the women of both groups
    Determinar el tiempo desde el inicio del tratamiento hasta el inicio del parto
    * Saber si existen diferencias en las condiciones obstétricas durante el tratamiento, durante el ingreso y durante los períodos de dilatación y expulsión con respecto al grupo control.

    * Saber si existen diferencias en los resultados neonatales, los efectos secundarios del tratamiento y las posibles complicaciones maternas entre las mujeres de ambos grupos.

    * Identificar si existen diferencias en las alteraciones en la dinámica uterina, riesgo de pérdida de bienestar fetal y uso de fármacos betamiméticos en mujeres de ambos grupos

    * Saber si las mujeres del grupo de control utilizan oxitocina con más frecuencia y en dosis más altas que las del grupo experimental. Así como las dosis de tratamiento para la inducción del fármaco en el parto.

    * Evaluar si hay diferencias en el número de cesáreas de ambos grupos. Conocer el grado de satisfacción de las mujeres de ambos grupos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Low- and medium-risk term pregnant women (not including pregnant
    women under age 18, grade I heart disease, high multiparity, and insufficient gestational control) between 40-41 w
    Mujeres embarazadas a término de riesgo bajo y medio (sin embarazo
    mujeres de menos de 18 años, enfermedad cardíaca de grado I, alta multiparidad y control gestacional insuficiente) entre 40-41 semanas de gestación
    E.4Principal exclusion criteria
    Pregnant women who do not want to participate in the project.

    * Mid-risk pregnant women out of the inclusion criteria, high and very high risk.

    * Pregnant women who do not understand the language.

    * Pregnant women whose delivery attendance is not going to be performed in our Hospital ( Clínic Hospital of Barcelone )

    * Pregnant women with anomalous fetal presentations according to the ultrasound of the third trimester: transverse, oblique and breech.

    * Premature rupture of membranes before initiating intervention.
    Mujeres embarazadas que no quieren participar en el proyecto.

    * Mujeres embarazadas de riesgo medio fuera de los criterios de inclusión, riesgo alto y muy alto.

    * Mujeres embarazadas que no entienden el idioma.

    * Mujeres embarazadas cuya parto no se realizará en nuestro Hospital (Clínic Hospital de Barcelona)

    * Mujeres embarazadas con presentación fetal anómala según el ultrasonido del tercer trimestre: transversal, oblicuo y con nalgas.

    * Rotura prematura de las membranas antes de iniciar la intervención.
    E.5 End points
    E.5.1Primary end point(s)
    Induction at delivery in low- and middle-risk pregnant women through acupuncture could lead to a reduction in the number of hospital admissions in the group of pregnant women with an increased risk of perinatal mortality, as in chronologically prolonged gestation, and specifically in the body mass index above 30% and maternal age over 40 years old, by 20%.
    La inducción al parto en embarazadas de riesgo bajo y medio a través de la acupuntura podría conducir a una reducción en el número de ingresos hospitalarios en el grupo de mujeres embarazadas con un mayor riesgo de mortalidad perinatal, como en la gestación cronológicamente prolongada y específicamente en el cuerpo Índice de masa superior al 30% y edad materna mayor de 40 años, en un 20%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Difference in hours between scheduled income and actual income.
    Diferencia en horas entre ingreso programado e ingreso real.
    E.5.2Secondary end point(s)
    Demographic data: age, nationality, ethnicity, name, Hª clinic
    ● Gestational age at delivery, expressed in weeks and days.
    ● Parity
    ● Anterior induction and previous type of delivery
    ● Size expressed in cm
    ● Weight expressed in grams
    ● BMI
    ● Obstetric risk
    ● Treatment of anterior acupuncture, either pre-gestational or during ongoing gestation.
    ● Performing any maneuver / method that can trigger labor (nipple stimulation, sexual intercourse, Hamilton maneuver, raspberry infusions, cinnamon, homeopathy ...).
    ● Professional acupuncturist who treats and values ​​the pregnant woman, start date, time, treated points and the duration of the session expressed in minutes.
    ● Obstetric admission conditions assessed by vaginal touch, taking into account the position, consistency and effacement of the cervix, dilatation of the cervix, and the Hodge plane in which the fetal presentation is. Bishop's Test.
    ● Information about the fetal cardiotocographic record, which we will catalog according to normal, atypical or pathological according to the fetal wellbeing protocol of Hospital Clinic - Maternidad, before performing the treatment with acupuncture and 60 'post treatment.
    ● Fetal RCTG Features: Baseline fetal heart rate. Short-term variability and the presence or absence of transient ascents, before performing the treatment with acupuncture and 60 'post-treatment.

    ● Dynamic Uterine Registry. Changes in uterine dynamics will be assessed: yes / no tachysystole (more than five contractions in ten minutes for at least 20 minutes), yes / no hypertonia (contraction lasting two minutes or more), bradystrothesis yes / no Less than three contractions in ten minutes for at least 20 minutes) dynamic uterine absence. Before performing the treatment with acupuncture and 60 'post-treatment.
    ● Reason for admission: labor / premature rupture of membranes / others.
    ● Income according to the expected date: Yes / No
    ● Number of acupuncture sessions performed prior to labor or before hospital admission.
    ● Induction method after induction failure with acupuncture according to the induction protocol at birth. Foley catheter, Misoprothol, Dinoprostone, Oxytocin.
    Foley probe time if this method is used for cervical maturation if acupuncture induction fails in minutes.
    ● Doses of misoprotol (50mcg dose) used.
    ● Dinoprostone time in minutes.
    ● Oxytocin time in minutes.
    ● Premature rupture of membranes: yes / no; Day and hour. Premature rupture of membranes (RPM) means the rupture of the ovular membranes before the onset of labor, with the consequent release of amniotic fluid.
    ● Intrapartum amniorrexis: spontaneous or artificial.
    ● Characteristics of amniotic fluid defined as clear, blood or meconium.
    ● Epidural anesthesia: yes / no.
    ● Duration in minutes of each stage of labor: dilation, expulsion, and delivery.
    ● Type of delivery: eutocic, vacuum, spatulas, forceps, cesarean in the course of delivery, urgent cesarean section.
    ● Reason for instrumented delivery / cesarean delivery.
    ● Use of betamimetics: yes / no.
    ● Treatment side effects by specifying the types of treatment used with either acupuncture or Foley, Misoprostol, Dinoprostone, Oxytocin treatments.
    ● Maternal complications: yes / no uterine rupture, yes / no postpartum haemorrhage. Minor postpartum haemorrhage (HPP) is defined as a hemorrhagic loss between 500 and 1000 ml with no clinical signs of shock ml. SE is defined as a higher PPH when the patient continues to bleed, or the estimate is> 1000 ml or, given a lower estimate, presents clinical signs of shock.
    ● Neonatal outcomes: sex (male, female); Weight expressed in grams; Apgar test score at minutes 1 and 5 of extrauterine life; Arterial pH of umbilical cord, expressed in a single figure with two decimal places; Advanced resuscitation yes / no; Admission to Neonatal Unit yes / no, cause of neonatal admission.
    ● Degree of satisfaction of pregnant women
    ●Datos demográficos : edad, nacionalidad, etnia, nombre , Hª clínica
    ●Edad gestacional en el momento del parto, expresada en semanas y días.
    ●Paridad
    ●Inducción anterior y tipo de parto anterior
    ●Talla expresada en cm
    ●Peso expresado en gramos
    ●IMC
    ●Riesgo obstétrico
    ●Tratamiento de acupuntura anterior, ya sea pre-gestacional o durante gestación en curso.
    ●Realización de alguna maniobra/ método que pueda desencadenar el parto (estimulación del pezón, relaciones sexuales, maniobra de Hamilton, infusiones de frambuesa, de canela, homeopatía…).
    ●Profesional acupuntor que trata y valora a la gestante, fecha de inicio, hora, puntos tratados y tiempo que dura la sesión expresado en minutos.
    ●Condiciones obstétricas al ingreso valoradas mediante tacto vaginal, teniendo en cuenta la posición, consistencia y borramiento del cuello uterino, la dilatación del mismo y el plano de Hodge en el que se encuentra la presentación fetal. Test de Bishop.
    ●Información sobre el registro cardiotocográfico fetal, que catalogaremos según sea normal, atípico o patológico según el protocolo de bienestar fetal del Hospital Clinic - Maternidad, antes de realizar el tratamiento con acupuntura y 60’ post tratamiento.
    ●Características RCTG fetal: Línea basal frecuencia cardíaca fetal. Variabilidad a corto plazo y presencia o no de ascensos transitorios, antes de realizar el tratamiento con acupuntura y 60’ post tratamiento.

    ●Registro Dinámica uterina. Se valorará alteraciones de la dinámica uterina: taquisistolia sí/no (más de cinco contracciones en diez minutos durante al menos 20 minutos), hipertonía sí/no (contracción que tiene una duración igual o superior a dos minutos), bradisistolia sí/no (menos de tres contracciones en diez minutos durante al menos 20 minutos) ausencia dinámica uterina. antes de realizar el tratamiento con acupuntura y 60’ post tratamiento.
    ●Motivo ingreso : trabajo de parto / rotura prematura de membranas/ otros.
    ●Ingreso según fecha prevista : Si / No
    ●Nº de sesiones de acupuntura realizadas antes de iniciar el trabajo de parto o antes del ingreso hospitalario.
    ●Método de inducción tras fracaso de inducción con acupuntura según el protocolo de inducción al parto Hospital clínic casa Maternidad. Sonda Foley, Misoprotol, Dinoprostona, Oxitocina.
    Tiempo de sonda Foley si se utiliza este método para maduración cervical si falla la inducción mediante acupuntura en minutos.
    ●Dosis de misoprotol (50mcg dosis) utilizados.
    ●Tiempo de Dinoprostona en minutos.
    ●Tiempo de Oxitocina en minutos.
    ●Rotura prematura de membranas: sí/no; día y hora. Se entiende por rotura prematura de membranas (RPM) la rotura de las membranas ovulares antes del inicio del parto, con la consiguiente salida de líquido amniótico.
    ●Amniorrexis intraparto: espontánea o artificial.
    ●Características del líquido amniótico definidos como clara, hemático o meconial.
    ●Anestesia peridural: sí/no.
    ●Duración en minutos de cada una de las etapas del parto: dilatación, expulsivo y alumbramiento.
    ●Tipo de parto: eutócico, vacuum, espátulas, fórceps, cesárea en curso de parto, cesárea urgente.
    ●Motivo del parto instrumentado/cesárea.
    ●Uso de betamiméticos: sí/no.
    ●Efectos secundarios al tratamiento especificando los tipos de tratamiento utilizados ya sea con acupuntura o los tratamientos mediante sonda Foley, Misoprostol, Dinoprostona, Oxitocina.
    ●Complicaciones maternas: rotura uterina sí/no, hemorragia posparto sí/no. Se define como hemarragia postparto (HPP) menor una pérdida hemñatica entre 500 i 1000 ml sin signos clínicos de shock ml. SE define como HPP mayor cuando el paciente continua sangrando, ó la estimación sea > 1000ml ó , siendo estimación menor, presente signos clínicos de shock.
    ●Resultados neonatales: sexo (hombre, mujer); peso expresado en gramos; puntuación del test de Apgar a los minutos 1 y 5 de vida extrauterina; pH arterial de cordón umbilical, expresado en una única cifra con dos decimales; reanimación avanzada sí/no; ingreso en Unidad de Neonatología sí/no, causa del ingreso neonatal.
    ●Grado de satisfacción de las gestantes
    E.5.2.1Timepoint(s) of evaluation of this end point
    Induction at birth in low- and middle-risk pregnant women through acupuncture

    Could reduce the number of hospital admissions in the group of pregnant women with the increased risk of perinatal mortality, as in chronologically prolonged gestation, and specifically in the body mass index 30% and the maternal age of More than 40 years, by 20%
    Inducción al nacer en mujeres embarazadas de riesgo bajo y medio a través de la acupuntura

    Podría reducir el número de ingresos hospitalarios en el grupo de mujeres embarazadas con mayor riesgo de mortalidad perinatal, como en la gestación cronológicamente prolongada, y específicamente en el índice de masa corporal del 30% y la edad materna de más de 40 años, en un 20%
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    clinical trial randomised trial to single blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    inserción de agujas en determinados puntos anatómicos para restablecer salud.
    control grup, habitual behavior
    E.8.2.4Number of treatment arms in the trial6
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    This Clinical Trial will evaluate the efficacy and safety of acupuncture to promote labor in pregnant women who need an induction at birth .
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 117
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state117
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The intention of this study is to try to get a term in a greater number of the mayor of women, thus avoiding the prolonged pregnancies and the maternal-fetal complications that can appear. Likewise, the percentage of inductions given to prolonged gestation, which may involve high health costs (days of hospital admission, visits, tests, etc.) and an increase in perinatal and maternal morbidity, will also be avoided.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-14
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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