Patients with stable coronary artery disease: The EUROPA study was a multicentre, international, randomised, double-blind, placebo-controlled clinical trial lasting 4 years.

In one double-masked, randomised, placebo-and active-controlled study, patients treated with NEVANAC had significantly less inflammation than those treated with placebo.

Another double-blind, placebo-controlled study of 82 patients was performed to determine whether Fabrazyme would reduce the rate of occurrence of renal, cardiac, or cerebrovascular disease or death.

At the end of treatment (over 6 or 8 weeks), significant efficacy of agomelatine 25-50 mg was demonstrated in 3 of the six short-term double-blind placebo-controlled studies.

An effective common system of export controls on dual-use items is necessary to ensure that the international commitments and responsabilities of the Member States, especially regarding non-proliferation, and of the European Union, are complied with.

37 representative of other classes of antihypertensive medicinal products (demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril).

Surveillance document forms and extracts thereof shall be drawn up in duplicate, one copy, marked "Holder's copy" and bearing the number 1, to be issued to the applicant, and the other, marked "Copy for the competent authority" and bearing the number 2, to be kept by the authority issuing the document.

The efficacy of Cervarix was assessed in two controlled, double-blind, randomised Phase II and III clinical trials that included a total of 19,778 women aged 15 to 25 years.

Two double-blind, randomised, placebo-controlled studies in adults with a BMI ≥ 28 kg/ m2 support the efficacy of orlistat 60 mg taken three times daily in conjunction with a hypocaloric, lower-fat diet.

In adults, levetiracetam efficacy has been demonstrated in 3 double-blind, placebo-controlled studies at 1000 mg, 2000 mg, or 3000 mg/ day, given in 2 divided doses, with a treatment duration of up to 18 weeks.

The once daily regimen of abacavir is supported by a 48 weeks multi-centre, double-blind, controlled study (CNA30021) of 770 HIV-infected, therapy-naïve adults.

One randomised, double blind, placebo controlled clinical study has compared the combination of abacavir, lamivudine and zidovudine to the combination of indinavir, lamivudine and zidovudine in treatment naive patients.

essential requirements specific to electronic-signature products must be met in order to ensure free movement within the internal market and to build trust in electronic signatures, without prejudice to Council Regulation (EC) No 3381/94 of 19 December 1994 setting up a Community regime for the control of exports of dual-use goods(5) and Council Decision 94/942/CFSP of 19 December 1994 on the joint action adopted by the Council concerning the control of exports of dual-use goods(6);

6 Efficacy against cholera Efficacy against cholera was assessed in three randomised double-blind placebo-controlled clinical trials conducted in Bangladesh (endemic region) and in Peru (non-endemic region).

Clinical efficacy Effect on fracture incidence The pivotal study was an 18-month double-blind, placebo-controlled, phase III study (TOP) of the effect of Preotact on fracture incidence in women with postmenopausal osteoporosis.

Levetiracetam efficacy was established in a double-blind, placebo-controlled study of 16 weeks duration, in patients 12 years of age and older suffering from idiopathic generalized epilepsy with myoclonic seizures in different syndromes.

As a consequence of different but complementary mechanisms of action, dual oral therapy of rosiglitazone with a sulphonylurea or metformin resulted in additive effects on glycaemic control in type 2 diabetic patients.

Immunogenicity following concomitant administration In a double-blind, controlled clinical trial, 762 adults 50 years of age and older were randomized to receive a single dose of ZOSTAVAX administered either concomitantly (N=382) or nonconcomitantly (N=380) with inactivated split influenza vaccine.

Clinical efficacy and safety The safety and efficacy of ustekinumabwas assessed in 1,996 patients in two randomised, double-blind, placebo-controlled studies in patients with moderate to severe plaque psoriasis and who were candidates for phototherapy or systemic therapy.

It was argued that as the Czech Republic was subject to the surveillance of exports under the double-checking system established by Council Regulation (EC) No 87/98(5), it should be excluded from the present anti dumping proceeding.

In a 52-week, randomized, double-blind, placebo-controlled clinical study, 96 patients between the ages of 5 and 31 years received Elaprase 0.5 mg/ kg every week (n=32) or 0.5 mg/ kg every other week (n=32), or placebo (n=32).

The efficacy of venlafaxine immediate-release as a treatment for major depressive episodes was demonstrated in five randomised, double-blind, placebo-controlled, short-term trials ranging from 4 to 6 weeks duration, for doses up to 375 mg/ day.

This list implements internationally agreed dual-use controls including the Wassenaar Arrangement, the Missile Technology Control Regime (MTCR), the Nuclear Suppliers' Group (NSG), the Australia Group and the Chemical Weapons Convention (CWC).

Efficacy and safety of Fabrazyme was evaluated in one study with children, one dose-finding study, two double-blind placebo-controlled studies, and one open-label extension study in both male and female patients.

The objective of this double-blind, randomised, placebo controlled trial was to determine whether inhaled nitric oxide would reduce the occurrence of death and/ or initiation of extracorporeal membrane oxygenation (ECMO).

Survival and tumour progression have been examined in five large controlled studies involving a total of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.

Additionally, nearly all patients received prophylactic treatment with antibiotics, according to clinical practice at each of the clinical trial sites 5 In two double-masked, randomised placebo-controlled studies, patients treated with NEVANAC had significantly less inflammation (aqueous cells and flare) from the early postoperative period through the end of treatment than those treated with placebo.

In order to enable the Member States and the Community to comply with their international commitments, Annex I to Regulation (EC) No 1334/2000 establishes the common list of dual-use items and technology referred to in Article 3 of that Regulation, which implements internationally agreed dual-use controls, including the Wassenaar Arrangement, the Missile Technology Control Regime, the Nuclear Suppliers Group, the Australia Group and the Chemical Weapons Convention.

The efficacy of venlafaxine prolonged-release capsules as a treatment for social anxiety disorder was established in four double-blind, parallel-group, 12-week, multi-center, placebo-controlled, flexible-dose studies and one double-blind, parallel-group, 6-month, placebo-controlled, fixed/ flexible-dose study in adult outpatients.

Regarding efficacy, the Applicant demonstrated the clinical efficacy of Oracea as monotherapy in reducing the papulo-pustular lesion count, through two Phase III double-blinded, randomized, placebo-controlled studies, including over 530 patients.

Therapy-naïve patients The combination of abacavir and lamivudine as a once daily regimen is supported by a 48 weeks multi-centre, double-blind, controlled study (CNA30021) of 770 HIV-infected, therapy-naïve adults.

The effectiveness of Neupro in the treatment of the signs and symptoms of idiopathic Parkinson 's disease was evaluated in a multinational drug development program consisting of four pivotal, parallel, randomized, double-blind placebo controlled studies.

In 2 multicenter, randomized, double-blind, active comparator-controlled, parallel-group phase III clinical studies, aprepitant was compared with ondansetron for the prevention of postoperative nausea and vomiting in 1,658 patients undergoing open abdominal surgery.

For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea The dose of Efficib should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.

For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea The dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.

In the Shingles Prevention Study (SPS), a placebo-controlled, double-blind clinical trial of ZOSTAVAX, 38546 subjects 60 years of age or older were randomized to receive a single dose of either ZOSTAVAX (n=19270) or placebo (n=19276).

In the 12-week double-blind, placebo-controlled trial, 9 % of patients treated with RISPERDAL CONSTA, compared with 6 % of patients treated with placebo, experienced a weight gain of ≥ 7 % of body weight at endpoint.

For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea The dose of Velmetia should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.

The efficacy of risperidone monotherapy in the acute treatment of manic episodes associated with bipolar I disorder was demonstrated in three double-blind, placebo-controlled monotherapy studies in approximately 820 patients who had bipolar I disorder, based on DSM-IV criteria.

An increased incidence in bone fractures in women was seen in a pooled analysis of adverse event reports of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years.

Clinical studies: The effectiveness of Neupro in the treatment of the signs and symptoms of idiopathic Parkinson 's disease was evaluated in a multinational drug development program consisting of four pivotal, parallel, randomized, double-blind placebo controlled studies.

Others An increased incidence in bone fractures in women was seen in a pooled analysis of adverse event reports of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years.

In a multicentre, double-blind, controlled study (CNA30024), 654 HIV-infected, antiretroviral therapy-naïve patients were randomised to receive either abacavir 300 mg twice daily or zidovudine 300 mg twice daily, both in combination with lamivudine 150 mg twice daily and efavirenz 600 mg once daily.

The efficacy of venlafaxine prolonged-release capsules as a treatment for panic disorder was established in two double-blind, 12-week, multi-center, placebo-controlled studies in adult outpatients with panic disorder, with or without agoraphobia.

The effect of fesoterodine 4 mg and 28 mg on the QT interval was thoroughly evaluated in a double-blind, randomised, placebo- and positive-controlled (moxifloxacin 400 mg) parallel group study with once-daily treatment over a period of 3 days in 261 male and female subjects aged 45 to 65 years.

A pooled analysis was conducted of adverse event reports of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.

Double blind controlled clinical or pharmacoclinical trials comparing cetirizine to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), of which quantified safety data are available, included more than 3200 subjects exposed to cetirizine.

A pooled analysis was conducted of adverse event reports of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration. A higher rate of

The European Union shall, in particular, promote and support efforts of the international community to further non-proliferation objectives regarding the exports of material, equipment and technology controlled under the Nuclear Suppliers Group Trigger and Dual Use Lists and the Missile technology Regime Annex.

Efficacy was also established in one long-term double-blind, placebo-controlled, parallel-group study of the long-term safety, efficacy, and prevention of relapse in adult outpatients who responded to open-label treatment.