The OPTI Study in Spain Looks at the History Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Inhaled Steroids.

NCT ID: NCT03611777

Last Updated: 2021-04-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

901 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-14

Study Completion Date

2020-01-31

Brief Summary

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This non-Interventional, descriptive, cross-sectional cohort and multicentre study will be conducted with COPD patients attended at Spanish Primary Care offices.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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subjects with Pulmonary Disease, Chronic Obstructive

Inhaled corticosteroid

Intervention Type DRUG

Drug

Interventions

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Inhaled corticosteroid

Drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent prior to participation
2. Female and male patient ≥ 40 years of age
3. Chronic Obstructive Pulmonary Disease (COPD) diagnosis more than 2 years before the study visit
4. Previously confirmed Chronic Obstructive Pulmonary Disease (COPD) diagnosis (post-bronchodilator FEV1/FVC ratio \<70%)
5. Clinical data available 2 years before the study visit
6. Ability to complete CAT - COPD Assessment Test

Exclusion Criteria

1. Current participation in any clinical trial involving a drug or device
2. A moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) during the study visit or within 4 weeks before the study visit
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mireia Canals, (+34) 93 404 58 77

Role: STUDY_CHAIR

[email protected]

Locations

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CS A Pontenova

A Pontenova, Lugo, , Spain

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CAP Abrera

Abrera, Barcelona, , Spain

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CS Zona VI

Albacete, , Spain

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CS Zona IV

Albacete, , Spain

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CS Nuestra Señora de la Oliva

Alcalá de Guadaira, Sevilla, , Spain

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EAP Carmen Calzado

Alcalá de Henares, Madrid, , Spain

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CS Alcasser

Alcasser, Valencia, , Spain

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CS La Chopera

Alcobendas, Madrid, , Spain

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CS Algeciras Norte

Algeciras, Cádiz, , Spain

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CS Algemesi

Algemesi, Valencia, , Spain

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CS Almonte

Almonte, Huelva, , Spain

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Consultorio Alpuente

Alpuente, Valencia, , Spain

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CS Argamasilla de Calatrava

Argamasilla de Calatrava, Ciudad Real, , Spain

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CS Baltar Sanxenxo

Baltar, Pontevedra, , Spain

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Consultorio Bañaderos

Bañaderos, Las Palmas, , Spain

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CAP Sant Marti (EAP Verneda Nord)

Barcelona, , Spain

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CAP Sants

Barcelona, , Spain

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EAP Vía Roma

Barcelona, , Spain

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CAP Casernes

Barcelona, , Spain

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CAP Chafarinas

Barcelona, , Spain

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CAP Trinitat Vella

Barcelona, , Spain

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Cap Sant Rafael

Barcelona, , Spain

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CAP Casanova

Barcelona, , Spain

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CAP Dr. Carles Ribas

Barcelona, , Spain

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EAP Guinardo

Barcelona, , Spain

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CS Bedman

Bedman, Jaén, , Spain

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Consultorio Médico Begíjar

Begíjar, Jaén, , Spain

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CS Benigánim

Benigánim, Valencia, , Spain

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C. S. Benimamet

Benimamet, Valencia, , Spain

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CS Santutxu

Bilbao, , Spain

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CS Comuneros

Burgos, , Spain

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CS Gamonal Antigua

Burgos, , Spain

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CS Matrona Antonia Mesa Fernández

Cabra, Córdoba, , Spain

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CS Olivillo

Cadiz, , Spain

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C.S. Callosa del Segura

Callosa de Segura, Alicante, , Spain

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C.S. Carballo

Carballo, A Coruña, , Spain

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CS Nuestra señora de Gracia

Carmona, Sevilla, , Spain

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CS Cartaya

Cartaya, Huelva, , Spain

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C.S. San Agustín

Castellon, , Spain

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CS Catarroja

Catarroja, Valencia, , Spain

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CAP Canaletas

Cerdanyola, Barcelona, , Spain

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CS Chapela

Chapela, Pontevedra, , Spain

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CS Ciudad Rodrigo

Ciudad Rodrigo Salamanca, , Spain

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CS Collado Villalba Estación

Collado Villalba, Madrid, , Spain

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CS Virgen de la Estrella 2

Coria Del Río, Sevilla, , Spain

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CS Jaime Vera

Coslada, Madrid, , Spain

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CS Cuenca IV

Cuenca, , Spain

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C.S. Cuntis

Cuntis, Pontevedra, , Spain

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Consultorio Guargacho

El Monte, Tenerife, , Spain

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CS Puerto de Santa María Sur

El Puerto de Santa María, Cádiz, , Spain

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CS San Miguel Basauri

Elexalde, Bizcaia, , Spain

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CAP Pubilla Casas

Esplugues de Llobregat, Barcelona, , Spain

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CS Lobillas

Estepona, Málaga, , Spain

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CS Favara

Favara, Valencia, , Spain

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CAP Figueres Ernest Lluch

Figueres, Girona, , Spain

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CAP Josep Masdevall

Figueres, Girona, , Spain

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CS Panaderas

Fuenlabrada, Madrid, , Spain

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CS Cuzco

Fuenlabrada, Madrid, , Spain

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CS Natahoyo

Gijón, , Spain

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CAP Montilivi

Girona, , Spain

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Consultorio Gorraiz

Gorráiz, , Spain

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CAP Hostalric

Hostalric, Girona, , Spain

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CS Huelva Centro

Huelva, , Spain

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CS Bulevar

Jaén, , Spain

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C.S. Jávea

Jávea, Alicante, , Spain

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EAP - Centre - L´Hospitalet de Llobregat

L'Hospitalet de Llobregat, Barcelona, , Spain

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CAP Bellvitge

L'Hospitalet de Llobregat, Barcelona, , Spain

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CS La Almunia de Doña Godina

La Almunia de Doña Godina, Zaragoza, , Spain

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CS La Bañeza II

La Bañeza, León, , Spain

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CS La Cañada

La Cañada, Almería, , Spain

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CS La Carlota

La Carlota, Córdoba, , Spain

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CS La Línea Poniente

La Línea de La Concepción, Cádiz, , Spain

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CS La Roda

La Roda, Albacete, , Spain

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CS Zubia

La Zubia, Granada, , Spain

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CS Laredo

Laredo, Cantabria, , Spain

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CS Las Cabezas de San Juan

Las Cabezas, Sevilla, , Spain

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CS San José

Las Palmas, , Spain

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CS Maspalomas

Las Palmas, , Spain

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CS Eras de Renueva

León, , Spain

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CS Loeches

Loeches, Madrid, , Spain

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CS Lora del Río Virgen de Setefilla

Lora Del Río, Sevilla, , Spain

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CS Los Barrios

Los Barrios, Cádiz, , Spain

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CS Lucena

Lucena, Córdoba, , Spain

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CS San Roque

Lugo, , Spain

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CS Montesa

Madrid, , Spain

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CS Goya

Madrid, , Spain

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CS Potosí

Madrid, , Spain

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CS Alcalá de Guadaira

Madrid, , Spain

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CS Abrantes

Madrid, , Spain

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CS Canal de Panamá

Madrid, , Spain

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CS Estrecho de Corea

Madrid, , Spain

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CS Arroyo Media Legua

Madrid, , Spain

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CS Villa de Vallecas

Madrid, , Spain

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CS Aquitania

Madrid, , Spain

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CS Villaamil

Madrid, , Spain

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CS General Fanjul

Madrid, , Spain

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CS Las Aguilas

Madrid, , Spain

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CS Entrevias

Madrid, , Spain

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CS Malagon

Malagon, Ciudad Real, , Spain

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CS Son Rullan

Mallorca, , Spain

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CS Mansilla de las Mulas

Mansilla de Las Mulas, León, , Spain

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C.M. Mataró

Mataró, , Spain

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CS Huelin

Málaga, , Spain

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CS Victoria

Málaga, , Spain

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CS Meliana

Meliana, Valencia, , Spain

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CS Mengibar

Mengibar, Jaén, , Spain

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CS Moguer

Moguer Huelva, , Spain

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CS Montoro

Montoro, Córdoba, , Spain

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CS dos de Mayo

Móstoles, Madrid, , Spain

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CS Dr. Luengo Rodríguez

Móstoles, Madrid, , Spain

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CS Neda

Neda, Coruña, , Spain

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CS Novelda

Novelda, Alicante, , Spain

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CS Orgiva

Orgiva, Granada, , Spain

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C.S. Osuna

Osuna, Sevilla, , Spain

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CS Jardinillos

Palencia, , Spain

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CS La Puebla

Palencia, , Spain

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CS Pintor Oliva

Palencia, , Spain

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CS Palos de la Frontera

Palos de La Frontera, Huelva, , Spain

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C.S. Parador

Parador de Las Hortichuelas, Almería, , Spain

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C. S. Paterna

Paterna, Valencia, , Spain

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CS Pedralba

Pedralba, Valencia, , Spain

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Consultorio Peñíscola

Peñíscola, Castellón, , Spain

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CS Pilas

Pilas, Sevilla, , Spain

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CS Polinya de Xuquer

Polinya de Xuquer, Valencia, , Spain

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CS Port de Pollença

Pollença, Baleares, , Spain

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CS Lérez

Pontevedra, , Spain

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CS Repelega

Portugalete, Bizkaia, , Spain

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CS Castaños

Portugalete, Vizcaya, , Spain

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CS Puebla de Cazalla

Puebla de Cazalla, Sevilla, , Spain

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CS Puerto Lumbreras

Puerto Lumbreras, Murcia, , Spain

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CS Puertollano I

Puertollano, Ciudad Real, , Spain

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CS Rute

Rute, Córdoba, , Spain

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CS Periurbana Sur

Salamanca, , Spain

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CS La Cuesta

San Cristóbal La Laguna, Tenerife, , Spain

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CS San Fernando Dr. Cayetano Roldán

San Fernando, Cádiz, , Spain

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C. S. San Juan

San Juán de Alicante, , Spain

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CS Sancti Spiritus

Sancti Spiritus, Salamanca, , Spain

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CS Sangüesa

Sangüesa, Navarra, , Spain

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CAP Montclar

Sant Boi de Llobregat, Barcelona, , Spain

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CAP Dr. Vilaseca

Santa Coloma Gramanet, Barcelona, , Spain

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CS San Miguel de Abona

Santa Cruz de Tenerife, , Spain

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CS El Doctoral

Santa Lucía de Tirajana, Las Palmas, , Spain

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CS Santa María del Camí

Santa Mª Del Camí, Baleares, , Spain

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CS Perello

Sueca, Valencia, , Spain

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CS Sueca

Sueca, Valencia, , Spain

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CS Tacoronte

Tacoronte, Tenerife, , Spain

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CS Titaguas

Titaguas, Valencia, , Spain

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CS Torredelcampo

Torre Del Campo, Jaén, , Spain

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CS Brújula

Torrejón de Ardoz Madrid, , Spain

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CS Covadonga

Torrelavega, Cantabria, , Spain

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CS Carihuela

Torremolinos, , Spain

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CS Tudela Este

Tudela, Navarra, , Spain

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CS Valdefuentes

Valdefuentes, Cáceres, , Spain

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CS Ingeniero Joaquim Benlloch

Valencia, , Spain

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C.S. Malvarrosa

Valencia, , Spain

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CS Barrio de la Luz

Valencia, , Spain

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CS Campanar

Valencia, , Spain

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CS Vélez Norte

Vélez-Málaga, , Spain

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CS La Doblada

Vigo, , Spain

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C.S. Coia Vigo

Vigo, , Spain

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C. S. Almassera de Tonda, Vila Joiosa

Vila Joiosa, Alicante, , Spain

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CAP María Bernades

Viladecans, Barcelona, , Spain

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C. S. Xunqueira de Ambia

Xunqueira de Ambia, Ourense, , Spain

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CS Seminario

Zagaroza, , Spain

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CS Virgen de la Concha

Zamora, , Spain

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CS Fuentes Norte

Zaragoza, , Spain

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CS Canal Imperial Venecia

Zaragoza, , Spain

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CS Casablanca

Zaragoza, , Spain

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CS Seminario

Zaragoza, , Spain

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Countries

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Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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1237-0070

Identifier Type: -

Identifier Source: org_study_id

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