9 229 patients treated with Abraxane in the randomized, controlled clinical trial were evaluated for safety.

The trial was prematurely terminated with 1667 randomised patients due to a numerically higher mortality in the facilitated PCI group receiving tenecteplase.

If the vehicle taken from the series does not satisfy the requirements of section 7.1.6.1 a further random sample of four vehicles must be taken from the series and subjected to the tests described in Annex XI, Appendix 1.

The samples must be taken randomly from different parts of the offered quantity and tested before or at the time of entry into the cold store designated by the intervention agency.

The primary analysis of this study was performed on the population of all patients randomly assigned to a treatment arm who received study drug (randomised and treated).

As far as possible, and particularly in trials where the effect of the product cannot be objectively measured, steps shall be taken to avoid bias, including methods of randomization and blinding.

The safety and efficacy of Raptiva in moderate to severe plaque psoriasis patients has been demonstrated in five randomized, double-blind, placebo-controlled trials at the recommended dose (n=1742).

If the card web is disturbed by the pre-treatment, select each test specimen by removing at random at least 16 small tufts of suitable and approximately equal size and then combine them.

As far as possible, and particularly in trials where the effect of the product cannot be objectively measured, steps shall be taken to avoid bias, including methods of randomisation and blinding.

Healthy young adult animals are randomly selected, marked to permit individual identification, and kept in their cages for at least 5 days prior to the start of the test, to allow for acclimatisation to the laboratory conditions.

Seed materials, cell banks, pools of serum or plasma and other materials of biological origin and, whenever possible, the source materials from which they are derived shall be tested for adventitious agents.

In clinical trials and post-marketing experience, accidental or intentional acute overdosage of aripiprazole alone was identified in adult patients with reported estimated doses up to 1,260 mg with no fatalities.

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).

For the vessels referred to in Annex I, section 2.1.2 these tests on test-pieces shall be replaced by a hydrostatic test on five vessels taken at random from each batch in order to check that they conform to the requirements of Annex I, section 2.1.2.

In this trial, 326 heroin-addicted subjects were randomly assigned to either Suboxone 16 mg per day, 16 mg buprenorphine per day or placebo tablets.

Orientated fibres (cards, webs, slivers, rovings) - From randomly selected parts of the laboratory bulk sample cut not less than 10 cross-sections each of mass approximately 1 g. Subject the laboratory test sample so formed to the pre-treatment.

In the second clinical study (ASSERT), 279 patients were randomized to receive either placebo (Group 1, n=78) or 5 mg/ kg infliximab (Group 2, n=201) at 0, 2 and 6 weeks and every 6 weeks to week 24.

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 order to check sensitivity, disks (4.3) dipped in the standard penicillin solution (5.2) must be placed randomly between the milk sample disks at a rate of at least 2 % of the number of milk sample disks and at least five standard disks should be used during each test.

Prevention of Venous Thromboembolic Events (VTE) in patients undergoing hip fracture surgery treated for up to 24 days following an initial prophylaxis of 1 week In a randomised double-blind clinical trial, 737 patients were treated with fondaparinux 2.5 mg once daily for 7 +/ - 1 days following hip fracture surgery.

Healthy young adult hens free from interfering viral diseases and medication, and without abnormalities of gait should be randomized and assigned to treatment and control groups and acclimatized to the laboratory conditions for at least 5 days prior to the start of the study.

Healthy young adult hens free from interfering viral diseases and medication and without abnormalities of gait should be randomized and assigned to treatment and control groups and acclimatized to the laboratory conditions for at least 5 days prior to the start of the study.

Biochemistry Six hens randomly selected from each of the treatment and vehicle control groups, and three hens from the positive control group (when this group is run concurrently), should be killed within a few days after dosing, and the brain and lumbar spinal cord prepared and assayed for neuropathy target esterase inhibition activity.

In a phase-III trial with 349 patients with suspected malignant glioma amenable to complete resection of contrast-enhancing tumour were randomised to fluorescence-guided resection after administration of 20 mg/ kg body weight 5-ALA HCl or conventional resection under white light.

Fixed Dose Combination The overall incidence of adverse events reported with Kinzalkomb was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).

Fixed Dose Combination The overall incidence of adverse events reported with PritorPlus was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).

Fixed Dose Combination The overall incidence of adverse events reported with MicardisPlus was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).

Member States shall take all measures necessary to ensure that the laboratories referred to in Article 7 of Directive 89/397/EEC comply with the general criteria for the operation of testing laboratories laid down in European Standard EN 45001 supplemented by standard operating procedures and the random audit of their compliance by quality assurance personnel, in accordance with the OECD principles No 2 and 7 of good laboratory practice as set out in Section II of Annex 2 to the Decision of the Council of the OECD of 12 May 1981 concerning the mutual acceptance of data in the assessment of chemicals.