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Drug Safety Patient-Reported Adverse Drug Event Questionnaire Part A

- 20/09/21 - 1 modulo, 19 itemgroups, 306 elementi, 1 linguaggio

Itemgroups: General Information, Drug use, Symptoms, Symptoms Eyes eyelids, Symptoms Ear, nose and throat swallowing, Symptoms Sweating blushing temperature flu, Symptoms Mouth lips speech, Symptoms Tongue teeth taste, Symptoms chest sleep apnea blood, Symptoms Bladder urination, Symptoms Intestines stomach vomiting, Symptoms Skin hair nails, Symptoms Genitals menopause menstruation, Symptoms Muscles bones joints, Symptoms Dizziness falling balance, Symptoms Head brain moods, Symptoms Sleep fatigue, Symptoms Eating drinking weight, Symptoms Infection edema fungal infection

Study description: Patient-Reported Adverse Drug Event Questionnaire for the evaluation of drug safety, Part A. Publication granted by Sieta de Vries. Publishing results based on the questionnaire should include the following reference: de Vries, S.T., Mol, P.G.M., de Zeeuw, D. et al. Drug Saf (2013) 36: 765. doi:10.1007/s40264-013-0036-8

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Questionnaires

- 30/01/21 - 1 modulo, 11 itemgroups, 25 elementi, 1 linguaggio

Itemgroups: Administrative Data, Physical Activity Scale for the Elderly (PASE), Lubben Social Network Scale (LSNS-6), PSQI Pittsburgh Sleep Quality Index, ESS (Eppworth sleepiness scale), RBDSQ - REM Sleep Disorder Questionnaire, LEQ (Proband), Big Five Inventory, ECog (Proband), ECog (External rating), FAQ

DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out. For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains different kinds of questionnaires which can not be illustrated completely. This form has to be filled out at baseline and all follow-ups. The Big Five Inventory (BFI-10) has to be filled out only at baseline.

Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550 - Subject-Completed Rating Scales & Questionnaires

- 01/12/20 - 1 modulo, 2 itemgroups, 9 elementi, 1 linguaggio

Itemgroups: Administrative Data, Subject-completed Rating Scales & Questionnaires

Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Subject-Completed Rating Scales & Questionnaires) is to be filled out at Visit 2, 4 and 6 and/or in case of Early Withdrawal.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Neuropsychiatric interview (NPI-Q) (Neuropsychiatrisches Intervies (NPI‐Q))

- 22/04/20 - 1 modulo, 2 itemgroups, 6 elementi, 1 linguaggio

Itemgroups: Administrative Data, Neuropsychiatric Interview (NPI-Q)

DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Neuropsychiatric interview (NPI-Q). It has to be filled in for baseline and for all follow-ups. Due to potential copyright on this questionnaire included in the DZNE DELCODE protocol, the NPI-Q will only be included as text result items in this version of the DELCODE forms. The respective score items will have a comment in their descriptions about this to distinguish them from score items that were already defined like that by DZNE. For more information see: DOI:10.1017/S1041610210001237 or npitest.net.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Minimal Mental State Examination (MMSE)

- 18/04/20 - 1 modulo, 2 itemgroups, 12 elementi, 2 lingue

Itemgroups: Administrative Data, Minimal Mental State Examination (MMSE)

DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the results of the Minimal Mental State Examination (MMSE) form. It has to be filled in for Baseline and all Follow-ups. For more information see: Folstein MF, Folstein SE and McHugh PR. Mini-Mental State: A practical method for grading the state of patients for the clinician, Journal of Psychiatric Research 1975; 12: 189-198

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Geriatric Depression Scale (GDS), Geriatric Anxiety Inventory – Short Form (GAI‐SF) (Geriatrische Depressionsskala (GDS) und GAI-SF)

- 14/04/20 - 1 modulo, 3 itemgroups, 21 elementi, 1 linguaggio

Itemgroups: Administrative Data, Geriatric Depression Scale (GDS), Geriatric Anxiety Inventory – Short Form (GAI‐SF)

DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Geriatric Depression Scale (GDS) and the Geriatric Anxiety Inventory – Short Form (GAI‐SF). It has to be filled in for Baseline and for all Follow-ups. For use of the questionnaire GDS no licence is required. For more information to the GDS see Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-83;17(1):37-49. Due to potential copyright on the questionnaire GAI-SF included in the DZNE DELCODE protocol, GAI-SF will only be included as text result item in this version of the DELCODE forms (at least until permission to publish is received from the original authors or becomes clear upon further research). The respective score items will have a comment in their descriptions about this to distinguish them from score items that were already defined like that by DZNE. For more information to GAI-SF see: Pachana, N., Byrne, G., Siddle, H., Koloski, N., Harley, E., & Arnold, E. (2007). Development and validation of the Geriatric Anxiety Inventory. International Psychogeriatrics, 19, 103-114. doi: 10.1017/S1041610206003504. Rozzini, L., Chilovi, B., Peli, M., Conti, M., Rozzini, R., Trabucchi, M., Padovani, A. (2009). Anxiety symptoms in mild cognitive impairment. International Journal of Geriatric Psychiatry, 24, 300-305. doi: 10.1002/gps.2106.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - BDI

- 15/11/19 - 1 modulo, 2 itemgroups, 6 elementi, 1 linguaggio

Itemgroups: Administrative Data, Beck Depression Inventory

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is used to record the results of the Beck Depression Index (BDI). To be collected at Visit 1 (Screening) and Visit 4.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - IVR Pre-Sleep and Post-Sleep Questionnaires

- 15/11/19 - 1 modulo, 2 itemgroups, 6 elementi, 1 linguaggio

Itemgroups: Administrative Data, Interactive Voice Response Pre- and Post-Sleep Questionnaire

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is used to record the results of the IVR Pre- and Post-Sleep Questionnaires.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Bedtime Diary - Worksheet for Investigators

- 15/11/19 - 1 modulo, 4 itemgroups, 13 elementi, 1 linguaggio

Itemgroups: Administrative Data, Bedtime Diary, Bedtimes ordered, Median Habitual Bedtime Calculation

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is used to calculate the subject's median habitual bedtime from their bedtime diary, to decide when the investigational product is to be taken (60 minutes before habitual bedtime). This form is filled in at least 8 days after the Screening Visit (Visit 1), and before Visit 2.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Subject Bedtime Diary

- 14/11/19 - 1 modulo, 2 itemgroups, 6 elementi, 1 linguaggio

Itemgroups: Administrative Data, Bedtime Diary

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). In this form, the subjects record their lights-out time for seven days following the Screening Visit (Visit 1). There is a seperate form for the calculations performed on this data by the investigators.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Benzodiazepine Withdrawal Symptom Questionnaire

- 12/11/19 - 1 modulo, 3 itemgroups, 8 elementi, 1 linguaggio

Itemgroups: Administrative Data, Date of Benzodiazepine Withdrawal Symptom Questionnaire, Benzodiazepine Withdrawal Symptom Questionnaire

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is used to record information on the Benzodiazepine Withdrawal Symptom Questionnaire, which is asked at Visits 4, 7 and the Day 14 Follow-Up. The test itself is protected by copyright.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - IVRS Compliance

- 12/11/19 - 1 modulo, 2 itemgroups, 6 elementi, 1 linguaggio

Itemgroups: Administrative Data, Sleep questionnaire

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is used to record whether the post-sleep questionnaire has been administered, and is to be filled in at Visits 2, 4, 7, in case of Early Withdrawal and at the Day 7 Follow-Up Visit.

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