FrancophonIA/ELRC3.0 huggingface dataset:
English: Cardiac events including cardiomyopathy, myocardial infarction, atrial fibrillation and ischaemic coronary artery disorders have been associated with interferon alfa treatment (see section 4.8).
Estonian: Alfainterferoonraviga on seostatud südamega seotud tüsistusi, sealhulgas kardiomüopaatiat, müokardiinfarkti, kodade virvendust ja südame isheemiatõbe (vt lõik 4.8).
English: The 250 micrograms/0.5 mL pre-filled pen has a grey push button.
Estonian: Pen-süstlil, milles on 250 mikrogrammi/0,5 ml, on hall süstenupp.
English: Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b
Estonian: Besremi 500 mikrogrammi/0,5 ml süstelahus pen-süstlis alfa-2b-ropeginterferoon
English: • History or presence of autoimmune disease
Estonian: • Autoimmuunhaigus (kaasuv või anamneesis).
English: You have to use a different injection site for each of the two pens.
Estonian: Kummagi pen-süstliga peate süsti tegema eri süstekohta.
English: Acute hypersensitivity
Estonian: Äge ülitundlikkus
English: Only limited pharmacokinetic data are available from the use of ropeginterferon alfa-2b in the elderly.
Estonian: Alfa-2b-ropeginterferooni farmakokineetika kohta eakatel on andmeid ainult piiratud hulgal.
English: Each pre-filled pen of 0.5 mL solution contains 250 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 500 micrograms/mL.
Estonian: Üks 0,5 ml pen-süstel sisaldab valgu baasil mõõdetuna 250 mikrogrammi alfa-2bropeginterferooni, mis vastab 500 mikrogrammile/ml.
English: Renal impairment
Estonian: Artralgia Väsimus
English: • Remove the outer needle cap from the needle.
Estonian: • Eemaldage pen-süstlilt kate.
English: Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b
Estonian: Besremi 250 mikrogrammi/0,5 ml süstelahus pen-süstlis alfa-2b-ropeginterferoon
English: Breast-feeding
Estonian: PEN-SÜSTLI SILT
English: Each pre-filled pen of 0.5 mL solution contains 500 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 1,000 micrograms/mL.
Estonian: Üks 0,5 ml pen-süstel sisaldab valgu baasil mõõdetuna 500 mikrogrammi alfa-2bropeginterferooni, mis vastab 1000 mikrogrammile/ml.
English: The pre-filled pen may be stored for a maximum of 30 days in the refrigerator (2 °C - 8 °C) when stored with the pen cap on and kept in the outer carton in order to protect from light.
Estonian: Kui pen-süstlil on kate ja seda hoitakse välispakendis, valguse ees kaitstult, võib seda külmkapis (2 °C...8 °C) hoida kuni 30 päeva.
English: The pharmacokinetic profile of ropeginterferon alfa-2b has not been determined in obese and underweighted patients.
Estonian: Rasvunud ja alakaalulistel patsientidel ei ole alfa-2b-ropeginterferooni farmakokineetilist profiili kindlaks määratud.
English: • Do not inject into skin that is irritated, reddened, bruised, infected or scarred in any way.
Estonian: • Ärge süstige piirkonda, kus täheldate ärritust, punetust, verevalumeid, põletikku või arme.
English: Very rare side effects (may affect up to 1 in 10,000 people): - idiopathic or thrombotic thrombocytopenic purpura (increased bruising, bleeding, decreased platelets, anaemia and extreme weakness) - myocardial ischemia (reduced blood flow to your heart muscle)
Estonian: Väga harvad kõrvaltoimed (võivad tekkida kuni 1 inimesel 10 000-st): - idiopaatiline või trombootiline trombotsütopeeniline purpur (sagenenud verevalumid, veritsus,
English: Liver disorders have been reported in patients after long-term ropeginterferon alfa-2b therapy (see section 4.8).
Estonian: Lõppstaadiumis neeruhaigusega patsientidele on alfa-2b-ropeginterferoon vastunäidustatud (vt lõik 4.3).
English: 19 (10.7) 6.3 n.r.
Estonian: 19 (10,7) 6,3 teateid pole teateid pole 18 (94,7)
English: No interaction studies have been performed with ropeginterferon alfa-2b.
Estonian: Alfa-2b-ropeginterferooni koostoimeid ei ole uuritud.
English: Ropeginterferon alfa-2b is contraindicated in patients with decompensated cirrhosis of the liver (see section 4.3).
Estonian: Dekompenseeritud maksatsirroosiga patsientidele on alfa-2b-ropeginterferoon vastunäidustatud (vt lõik 4.3).
English: Increased liver enzyme levels have been observed in patients treated with ropeginterferon alfa-2b.
Estonian: Alfa-2b-interferooniga ravitud patsientidel on täheldatud maksaensüümide suurenenud sisaldust.
English: Rare side effects (may affect up to 1 in 1,000 people): - bipolar disorders (mood disorders with episodes of sadness and excitement), mania (extreme excitement or unreasonable enthusiasm) - cardiomyopathy (diseases that affect the heart muscle), angina pectoris (a severe chest pain as a result of blockage of the heart vessels) - liver failure
Estonian: Harvad kõrvaltoimed (võivad tekkida kuni 1 inimesel 1000-st): - bipolaarne häire (meeleoluhäire, millele on iseloomulikud kurbuse ja erutuse episoodid), maania
English: Complete haematological responsea Complete haematological responsea and improvement in disease burdenb a defined as haematocrit <45% without phlebotomy (at least 3 months since last phlebotomy), platelets <400 x 109/L and leukocytes <10 x 109/L.
Estonian: a Määratletud kui hematokrit ilma flebotoomiata < 45% (viimasest flebotoomiast möödas vähemalt
English: Treatment with ropeginterferon alfa-2b should be discontinued when, despite dose reduction, the increase in liver enzyme levels is progressive and clinically significant.
Estonian: Kui maksaensüümide sisaldus annuse vähendamisele vaatamata progresseeruvalt ja kliiniliselt oluliselt suureneb, tuleb ravi alfa-2b-ropeginterferooniga lõpetada.
English: Infections and infestations common respiratory tract infection, rhinitis, fungal skin infection uncommon oral herpes, herpes zoster, oral candidiasis, sinusitis, oesophageal candidiasis, vulvovaginal mycotic infection, hordeolum, onychomycosis
Estonian: Huule- ja suuõõneherpes, herpes zoster, suuõõne kandidiaas, sinusiit, söögitoru kandidiaas, vulvovaginaalne seeninfektsioon, odraiva, onühhomükoos
English: Liver enzymes and hepatic function should be regularly controlled in patients with longterm ropeginterferon alfa-2b therapy.
Estonian: Pikaajalist alfa-2b-ropeginterferoon-ravi saavatel patsientidel tuleb regulaarselt kontrollida maksaensüümide sisaldust ja maksafunktsiooni.
English: Simponi received a marketing authorisation valid throughout the EU on 1 October 2009.
Estonian: Simponi on saanud müügiloa, mis kehtib kogu ELis, 1. oktoobril 2009.
English: It is used to treat the following diseases:
Estonian: Seda kasutatakse järgmiste haiguste ravimiseks.
English: Simponi (golimumab)
Estonian: Simponi (golimumaab)
English: What measures are being taken to ensure the safe and effective use of Simponi?
Estonian: Mis meetmed võetakse, et tagada Simponi ohutu ja efektiivne kasutamine?
English: This overview was last updated in 02-2019.
Estonian: Kokkuvõtte viimane uuendus: 02.2019.
English: Other information about Simponi
Estonian: Muu teave Simponi kohta
English: Further information on Simponi can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/simponi.
Estonian: Lisateave Simponi kohta on ameti veebilehel: ema.europa.eu/en/medicines/human/EPAR/simponi.
English: The European Medicines Agency decided that Simponi's benefits are greater than its risks and that it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Simponi kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: What is Simponi and what is it used for?
Estonian: Mis on Simponi ja milleks seda kasutatakse?
English: As for all medicines, data on the use of Simponi is continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Simponi kasutamise kohta pidevat järelevalvet.
English: Due to an increased risk of infection, patients taking Simponi must be monitored closely for infections, including tuberculosis, during and for up to 5 months after treatment.
Estonian: Infektsiooniriski suurenemise tõttu tuleb Simponit kasutavaid patsiente hoolikalt jälgida infektsioonide, sealhulgas tuberkuloosi suhtes ravi ajal ja kuni 5 kuud pärast ravi.
English: This was assessed after 6 weeks in the first study and after 54 weeks in the second study.
Estonian: Sümptomeid hinnati esimeses uuringus 6 nädala järel ja teises uuringus 54 nädala järel.
English: The most serious side effects include serious infections, such as sepsis (blood infection), pneumonia (lung infection), tuberculosis and infections due to fungi or yeasts, demyelinating disorders (disorders suggesting damage to the protective sheath around nerves, such as changes to vision and weak arms or legs), re-activation of hepatitis B (a disease of the liver due to infection with the hepatitis B virus), congestive heart failure (a heart disease), lupus-like syndrome, blood reactions, severe allergic reactions, vasculitis (inflammation of the blood vessels), and lymphoma and leukaemia (types of cancer of the white blood cells).
Estonian: Kõige raskemad kõrvalnähud on rasked infektsioonid, näiteks sepsis (nakkusveresus), kopsupõletik, tuberkuloos, seen- või pärmnakkused, demüelinisatsioonihäired (närve ümbritseva kaitsekesta kahjustustest tulenevad häired, näiteks nägemishäired ja jäsemenõrkus), Bhepatiidi (B-hepatiidi viiruse infektsioonist tingitud maksahaigus) taasägenemine, kongestiivne südamepuudulikkus (teatud südamehaigus), luupuselaadne sündroom, verereaktsioonid, rasked allergiareaktsioonid, vaskuliit (veresoonte põletik) ning lümfoom ja leukeemia (leukotsüütide ehk vere valgeliblede teatud vähid).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Simponi have also been included in the summary of product characteristics and the package leaflet.
Estonian: Simponi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: This study also showed that patients who received Simponi had greater improvements in carrying out everyday tasks (such as dressing, eating and walking) after 24 weeks.
Estonian: Uuring tõendas ka, et Simponit kasutanud patsientidel paranes igapäevaste toimingute (nt riietumine, söömine, kõndimine) sooritamise võime 24 nädala järel rohkem.
English: Side effects reported with Simponi are carefully evaluated and any necessary action taken to protect patients.
Estonian: Simponi kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: For more information about using Simponi, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Simponi kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Treatment with Simponi and methotrexate was not compared with placebo or any other treatment.
Estonian: Ravi Simponi ja metotreksaadiga ei võrreldud platseebo ega ühegi muu raviviisiga.
English: The main measure of effectiveness was the number of patients who responded to treatment, based on the number and severity of symptoms.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kellel tekkis ravivastus sümptomite arvu ja raskuse vähenemisena.
English: How does Simponi work?
Estonian: Kuidas Simponi toimib?
English: What are the risks associated with Simponi?
Estonian: Mis riskid Simponiga kaasnevad?
English: By blocking TNF-α, golimumab reduces the inflammation and other symptoms of these diseases.
Estonian: Golimumaab vähendab TNF- blokeerimisega põletikku ja haiguste muid sümptomeid.
English: Simponi is an anti-inflammatory medicine.
Estonian: Simponi on põletikuvastane ravim.
English: Simponi is used in combination with methotrexate (a medicine that acts on the immune system).
Estonian: Simponit kasutatakse koos metotreksaadiga (immuunsüsteemi mõjutav ravim).
English: Patients treated with Simponi must be given a reminder card that summarises the safety information about the medicine and when to seek medical advice.
Estonian: Simponit kasutavatele patsientidele tuleb anda hoiatuskaart, kus on esitatud ravimi kokkuvõtlik ohutusteave ja selgitatud, millal tuleb pöörduda arsti poole.
English: It is used in children from 2 years of age who have not responded adequately to treatment with methotrexate.
Estonian: Seda kasutatakse vähemalt 2-aastastel lastel, kellel ei ole tekkinud metotreksaadiga piisavat ravivastust.
English: Simponi is used in combination with methotrexate.
Estonian: Simponit kasutatakse koos metotreksaadiga.
English: For polyarticular juvenile idiopathic arthritis, 173 patients between 2 and 18 years old who had not responded adequately to treatment with methotrexate were treated for 12 weeks with Simponi and methotrexate.
Estonian: Lapseea idiopaatiline artriidi ravis raviti 173 2-18aastast patsienti, kel ei olnud tekkinud metotreksaadiga piisavat ravivastust, 12 nädala jooksul Simponi ja metotreksaadiga.
English: Patients should show this card when seeing a healthcare professional, so that they are aware that the patient is using Simponi.
Estonian: Seda kaarti tuleb arstile näidata, et ta teaks, et patsient kasutab Simponit.
English: The most common side effects with Simponi are upper respiratory tract infections such as infections of the nose, throat or voice box.
Estonian: Simponi kõige sagedamad kõrvalnähud on ülemiste hingamisteede infektsioonid (nakkused), näiteks nina-, neelu- ja kõriinfektsioonid.
English: Simponi has been shown to be effective at reducing the number and severity of symptoms in patients with the conditions for which it is authorised.
Estonian: Simponi osutus efektiivseks kõikide seisundite sümptomite arvu ja raskuse vähendamisel, mille raviks see on heaks kiidetud.
English: This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Simponi is used to treat.
Estonian: See aine osaleb põletiku tekitamisel ning selle sisaldus on suur patsientidel, kelle haigusi ravitakse Simponiga.
English: How is Simponi used?
Estonian: Kuidas Simponit kasutatakse?
English: Of these patients, 87% of (151 out of 173) had 30% reduction in the number and severity of symptoms after 16 weeks.
Estonian: Neist 87%-l (151 patsienti 173st) vähenesid sümptomite arv ja raskus 16 nädala järel 30%.
English: What benefits of Simponi have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Simponi kasulikkus?
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body.
Estonian: Simponi toimeaine golimumaab on monoklonaalne antikeha (teatud valk), mis tunneb ära antigeeni (organismi teatud rakkudes leiduva spetsiifilise struktuuri) ja seondub sellega.
English: Data from X-rays taken before and after two years of treatment showed less joint damage in patients receiving Simponi than in those receiving placebo.
Estonian: Enne ja pärast kaheaastast ravi tehtud röntgenuuringute andmetel esines Simponi uuringurühmas vähem liigesekahjustusi kui platseeborühmas.
English: • polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints).
Estonian: • Lapseea idiopaatiline artriit (haruldane lapseea haigus, kus põletik on mitmes liigeses).
English: After training, patients may inject themselves with Simponi if their doctor agrees.
Estonian: Arsti nõusolekul tohivad patsiendid süstida endale Simponit ise, kui nad on saanud asjakohase väljaõppe.
English: Simponi must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).
Estonian: Simponit ei tohi kasutada patsiendid, kellel on tuberkuloos, muud rasked infektsioonid või mõõdukas või raske südamepuudulikkus.
English: The recommended dose depends on the disease Simponi is used to treat and the response of the patient.
Estonian: Soovitatav annus sõltub ravitavast haigusest ja patsiendi ravivastusest.
English: For the full list of restrictions with Simponi, see the package leaflet.
Estonian: Simponi kohta teatatud piirangute täielik loetelu on pakendi infolehel.
English: It can be used in adults who have not responded adequately to other treatments including methotrexate whose disease is moderate to severe, and in patients who have not previously been treated with methotrexate whose disease is severe and progressive;
Estonian: Simponit tohib kasutada mõõduka kuni raske reumatoidartriidiga täiskasvanutel, kellel ei ole muude ravimitega, sealhulgas metotreksaadiga tekkinud piisavat ravivastust, ning raske ja progresseeruva haigusega patsientidel, keda ei ole varem metotreksaadiga ravitud.
English: For non-radiographic axial spondyloarthritis, Simponi was compared with placebo over 16 weeks in one main study involving 198 patients who had the disease without evidence of ankylosing spondylitis but with signs of inflammation and who had not responded adequately to treatment with NSAIDs.
Estonian: Radioloogilise kinnituseta aksiaalse spondüloartriidi ravis võrreldi Simponit platseeboga 16 nädala jooksul ühes põhiuuringus, milles osales 198 patsienti, kelle haigusega kaasnesid põletikunähud, kuid mitte anküloseeriva spondüliidi nähud, ja kellel ei olnud NSAID-ravimitega tekkinud piisavat ravivastust.
English: • active and progressive psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Estonian: • Aktiivne ja progresseeruv psoriaatiline artriit (punaseid ketendavaid nahalaike ja liigesepõletikku põhjustav haigus).
English: For the full list of side effects reported with Simponi, see the package leaflet.
Estonian: Simponi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Simponi is used in adults who have not responded adequately to other treatments.
Estonian: Simponit kasutatakse patsientidel, kellel ei ole muu raviga tekkinud piisavat ravivastust.
English: The first study, involving 1,065 patients, compared different doses of Simponi with placebo as induction treatment.
Estonian: Esimeses uuringus (1065 patsienti) võrreldi Simponi eri annuseid platseeboga (algannus).
English: In the third study, in patients who had not been previously treated with either methotrexate or another anti-TNF-α, after 24 weeks, 40% of patients (64 out of 159) who received Simponi with methotrexate achieved 50% reductions compared with 29% of patients (47 out of 160) who received placebo and methotrexate.
Estonian: Kolmandas uuringus oli patsientidest, keda ei olnud varem ravitud metotreksaadiga või kes ei olnud saanud TNF--vastast ravi, neid, kelle sümptomite arv vähenes 24 nädala järel 50%, Simponit koos metotreksaadiga kasutanud uuringurühmas 40% (64 patsienti 159st) ja platseebot koos metotreksaadiga kasutanud uuringurühmas 29% (47 patsienti 160st).
English: The second study, involving 1,228 patients, compared Simponi 50 or 100 mg with placebo as maintenance treatment.
Estonian: Teises uuringus (1228 patsienti) võrreldi Simponi 50 mg ja 100 mg annuseid platseeboga (säilitusannus).
English: • active rheumatoid arthritis (a disease causing inflammation of the joints).
Estonian: • Aktiivne reumatoidartriit (liigesepõletikku põhjustav haigus).
English: Golimumab has been designed to attach to and block a substance in the body called tumour necrosis factor alpha (TNF-α).
Estonian: Golimumaab seondub spetsiifiliselt organismis sisalduva virgatsaine kasvaja -nekroositeguriga (TNF-) ja blokeerib selle.
English: Simponi can only be obtained with a prescription and treatment must be initiated and supervised by a qualified doctor who has experience in the diagnosis and treatment of the diseases that Simponi is used to treat.
Estonian: Ravi sellega tohib alustada üksnes eriarst, kes on kogenud nende haiguste diagnostikas ja ravis, mille raviks Simponit kasutatakse, ning ravi peab toimuma tema järelevalve all.
English: For rheumatoid arthritis, Simponi was compared with placebo (a dummy treatment) in three studies involving 1,542 patients with moderate to severe rheumatoid arthritis, including patients who had not received or responded adequately to other treatments.
Estonian: Reumatoidartriidi ravis võrreldi Simponit platseeboga (näiv ravim) kolmes uuringus, milles osales kokku 1542 mõõduka kuni raske reumatoidartriidiga patsienti (sealhulgas patsiendid, kes ei olnud saanud muud ravi või kellel ei olnud tekkinud muu raviga piisavat ravivastust).
English: In the first study, in which patients were also given methotrexate, after 14 weeks, 55% patients who received Simponi (49 out of 89) achieved 20% reductions compared with 33% (44 out of 133) of patients who received placebo.
Estonian: Esimeses uuringus, kus patsiendid kasutasid ka metotreksaati, oli patsiente, kelle sümptomite arv vähenes 14 nädala järel 20%, Simponi uuringurühmas 55% (49 patsienti 89st) ja platseeborühmas 33% (44 patsienti 133st).
English: An overview of Simponi and why it is authorised in the EU
Estonian: Ülevaade ravimist Simponi ja ELis müügiloa väljastamise põhjendus
English: It can be used alone or in combination with methotrexate;
Estonian: Simponit tohib kasutada ainsa ravimina või koos metotreksaadiga.
English: Simponi contains the active substance golimumab.
Estonian: Ravim sisaldab toimeainena golimumaabi.
English: For ulcerative colitis, Simponi was compared with placebo in two main studies in patients who had not responded to or could not use other treatments.
Estonian: Haavandilise koliidi ravis võrreldi Simponit platseeboga kahes põhiuuringus patsientidel, kellel ei olnud muu raviga tekkinud ravivastust või kes ei saanud muud ravi kasutada.
English: For psoriatic arthritis, Simponi was compared with placebo over 24 weeks in one main study involving 405 patients who had not responded adequately to other treatments.
Estonian: Psoriaatilise artriidi ravis võrreldi Simponit platseeboga 24 nädala jooksul ühes põhiuuringus, milles osales 405 patsienti, kellel ei olnud muu raviga tekkinud piisavat ravivastust.
English: For ankylosing spondylitis, Simponi was compared with placebo over 24 weeks in one main study involving 356 patients who had not responded adequately to other treatments.
Estonian: Anküloseeriva spondüliidi ravis võrreldi Simponit platseeboga 24 nädala jooksul ühes põhiuuringus, milles osales 356 patsienti, kellel ei olnud muu raviga tekkinud piisavat ravivastust.
English: Simponi is used in adults who have not responded adequately to, or cannot use, conventional treatment;
Estonian: Simponit kasutatakse patsientidel, kellel ei ole tavapärase raviga tekkinud piisavat ravivastust või kellele see ei sobi.
English: In the second study, around 50% of patients receiving maintenance treatment with Simponi 100 mg and around 47% of those given Simponi 50 mg responded to treatment after 54 weeks, compared with around 31% of patients given placebo.
Estonian: Teises uuringus oli patsiente, kellel tekkis 54 nädala järel ravivastus, Simponi 100 mg säilitusannuse uuringurühmas ligikaudu 50% ja platseeborühmas ligikaudu 31%.
English: • axial spondyloarthritis (a disease causing inflammation and pain in the joints of the spine), including: - adults with severe active ankylosing spondylitis who have not responded adequately to other treatments; - adults with severe non-radiographic axial spondyloarthritis (when there are objective signs of inflammation but no abnormalities seen on x-ray) who have not responded adequately or are intolerant to anti-inflammatory medicines called non-steroidal anti-inflammatory drugs (NSAIDs);
Estonian: • Aksiaalne spondüloartriit (lülisamba liigeste põletikku ja valu põhjustav haigus), sealhulgas täiskasvanutel, kellel on aktiivne ja raske anküloseeriv spondüliit ja kellel ei ole muu raviga tekkinud piisavat ravivastust;
English: Of the patients who received Simponi, 59% (82 out of 138) had 20% reductions in the number and severity of symptoms after 14 weeks, compared with 22% of patients who were given placebo (17 out of 78).
Estonian: Simponi rühmas oli patsiente, kellel sümptomite arv ja raskus vähenesid 20% 14 nädala järel, 59% (82 patsienti 138st) ja platseeborühmas 22% (17 patsienti 78st).