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Note: The remaining sections of this FDAAA 801 and the Final Rule page do not discuss requirements or exceptions for pediatric postmarket surveillances of device products.

See the relevant regulatory sections listed in the blue box below for more information.

Regulations (42 CFR Part 11)

Key regulatory provisions and related discussions in the Final Rule (81 FR 64981) include:

The following types of studies are not subject to the registration and results submission requirements of section 402(j) of the PHS Act, including its implementing regulations (see the note below the bulleted list). Note that this is not a complete list.

Note: If a responsible party voluntarily submits clinical trial information for a clinical trial that is not otherwise subject to the registration and results submission requirements, the responsible party may have to comply with certain requirements under section 402(j) of the PHS Act and its implementing regulations.

Regulations (42 CFR Part 11)

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The responsible party (that is, the sponsor or designated PI) for an ACT must submit the required clinical trial information no later than 21 days after enrollment of the first participant.

For ACTs that were 1) initiated on or before September 27, 2007, and 2) ongoing as of December 26, 2007, the following applies:

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(PDF) and the following FAQs for more information.

Regulations (42 CFR Part 11)

Overall, the final rule specifies requirements for registering applicable clinical trials at ClinicalTrials.gov. It requires that the responsible party register an applicable clinical trial not later than 21 calendar days after enrolling the first human subject (also referred to as participant or subject) (81 FR 64982).

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Regulations (42 CFR Part 11)

The final rule addresses the statutory requirement for the submission of summary results information for applicable clinical trials of drug products (including biological products) and device products that are approved, licensed, or cleared by FDA. It also extends the requirement for results information submission to applicable clinical trials of drug products (including biological products) and device products that are not approved, licensed, or cleared by FDA. The rule requires the submission of data in a tabular format summarizing participant flow; demographic and baseline characteristics; primary and secondary outcomes, as well as results of any scientifically appropriate statistical tests; and adverse event information. In addition, the rule requires the submission of the full protocol and statistical analysis plan (if a separate document) (81 FR 64983).

For information on regulatory requirements, see 42 CFR Part 11 . In particular, see:

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In general, results information for an ACT subject to the results information submission requirements must be submitted by the responsible party no later than 12 months after the primary completion date.

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September 11, 2014

This training system is probably unlike anything you are used to seeing. That's exactly what you need. For six weeks give this program everything you've got and you'll be well on your way to new strength and muscular development.

"Undulating Periodization has proven to be especially effective in inducing maximum strength gains."

Trainers, gym-goers, writers and athletes in the fitness industry tend to hype up or over-exaggerate the latest training breakthrough. Everything they have tried seems to be the best system ever. Although any program will work for a while, and no program will work forever, there still appears to be a search for the MAGICAL or PERFECT program. Readers of Bodybuilding.com will know that this is not the case - there is no such thing as the perfect program.

However, the very search for the magical training program has yielded some fascinating training methods.

Although several of these systems are based on nothing more than anecdotal opinion, a recent method has surfaced that has the stamp of science approval on it. Is it the perfect program? Doubtful. Is it perhaps the most effective training method for the more advanced trainee? Quite possibly.

Recent published research from Arizona State University has shown that a method of structuring the set and rep protocols in a vastly different manner (called undulating Periodization ) has proven to be especially effective in inducing maximum strength gains, when compared to traditional linear or alternating Periodization models.

Linear Periodization is when the reps are decreased each successive phase and the loads are increased e.g. phase one 15 reps, phase two 12 reps, phase three 10 reps, phase four 8 reps.

Alternating Periodization is when the trainee switches between higher reps and lower reps at each phase - e.g. phase one 15 reps, phase two 8 reps, phase three, 12 reps, phase four 6 reps etc

Undulating Periodization takes the adjusting of rep protocols one step farther. This system actually adjusts the rep bracket with each workout.

Traditional thinking states that the body adapts to a workout in as little as 6 exposures. In actuality - the body adapts to the rep range the fastest, and the exercise selection the slowest. So we need to change the rep bracket more often than we change the exercises. Typically a trainee will change the exercises first - not the most effective training system.

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Tiempo de lectura 3 min

Investigadores de la Escuela de Salud Pública de Harvard (Boston, EE UU) afirman que el consumo de fibras de cereal y granos enteros está asociado con un menor riesgo de muerte para patologías crónicas como cáncer, enfermedades cardiorrespiratorias o diabetes, que varía según la dolencia.

El trabajo apunta que el consumo de una media de 34 gramos de cereal al día en granos enteros –toda la semilla de una planta comestible formada por el germen, el salvado y la espora de cereales como el trigo , la avena y quinoa– se asocia con una reducción del 17% del riesgo de muerte prematura, en comparación con las personas que consumen un promedio de 3,98 gramos.

34 gramos

Los granos de cereal completos son una fuente rica de fibra dietética y otros nutrientes como minerales y antioxidantes. Asimismo, la ingesta media de 10,22 gramos al día de fibras de cereal se asocia con una reducción del 19% de riesgo de muerte prematura en comparación con aquellos que consumen una media de 2,02 gramos al día.

Una dieta sana y una vida saludable

Para Lu Qi , director del estudio, estos hallazgos “deben motivar ensayos clínicos y estudios experimentales que den mayor testimonio sobre los efectos beneficiosos para la salud de los granos enteros y sus posibles compuestos eficaces como la fibra y otros nutrientes. El objetivo último es explorar los efectos metabólicos de estos componentes”.

efectos beneficiosos para la salud

Es más, los científicos de Harvard encontraron que, incluso cuando se tuvieron en cuenta factores como el estado de salud, la actividad física y el grado de obesidad de los participantes, el porcentaje de riesgo de muerte prematura se reducía de forma similar.

El consumo elevado de cereales integrales se asocia con un 11% y un 48% de menor riesgo de muerte por enfermedades respiratorias y diabetes

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