Inclusion/Exclusion Criteria Clause Samples

Inclusion/Exclusion Criteria. Otherwise healthy ambulatory postmenopausal women who participated in, and who completed 18 months of treatment with either blinded Abaloparatide-SC or blinded Placebo in Study BA058-05-003, are scheduled to complete or have completed the End-of-Treatment visit (Visit 9 in Study BA058-05-003), and who have provided a new written informed consent for the Extension Study, are eligible for enrollment into this study. Participants must be no more than 40 days from Visit 9 in Study BA058-05-003 to be eligible for this study. The physical examinations and clinical laboratory measurements from the End-of-Treatment visit from Protocol BA058-05-003 (Visit 9) of the BA058-05-003 study will provide baseline data for this Extension Study. In addition, the subjects must, in the opinion of the Investigator, be appropriate candidates for treatment with alendronate. Subjects will not be enrolled if they experienced a treatment-related SAE as assessed by the Investigator, or if they were withdrawn from Study BA058-05-003 for any reason. Specific inclusion and exclusion criteria are described in Section 4.1 and Section 4.2, respectively.

Inclusion/Exclusion Criteria. All inclusion and exclusion criteria will be reviewed and documented by the investigator or qualified designee to ensure that the patient qualifies for the trial.

Inclusion/Exclusion Criteria. Inclusion criteria: i. Age > 18 years. ii. Previous diagnosis of RRMS or PPMS by 2010 revised ▇▇▇▇▇▇▇▇ criteria.(20) iii. Current SPMS or PPMS. iv. Progression of MS in the previous 2 years defined by medical record or reliable historical interview as: a. Non relapse-related MS decline resulting in a 0.5 step change in EDSS, decline in T25FW, or other clinically documented decline (can be assigned retrospectively) if not on a DMT, OR b. If currently on a DMT, non-relapse-related MS decline resulting in a 0.5 step change in EDSS, decline in T25FW, or other clinically documented decline (can be assigned retrospectively) while on the current DMT taken continuously for at least 1 year prior to enrolment. v. Able to give informed consent and to adhere to study procedures. vi. EDSS 3.0 to 6.5. i. A self-reported medical or neurological problem other than MS that is a cause of progressive or fluctuating gait dysfunction (e.g. worsening neuropathy, uncontrolled lower extremity arthritis, uncontrolled cardiopulmonary disease). Fixed and/or stable conditions of greater than 1 year that affect their gait are permitted (e.g. joint replacement, stable lumbar stenosis, remote alcoholism, remote stroke, etc.). ii. MRI constraints (metal implants including pacemaker, devices with electrodes, or shrapnel, excessive weight per site MRI requirements, need for sedation with non-oral agents due to claustrophobia or muscle spasticity). iii. MS clinical relapse in the 1 year prior to enrolment. iv. Unable to follow directions in English as standardized scales are not all validated in other languages. v. Current major disease or disorder other than MS (e.g., cancer, renal disease, end-stage cardiopulmonary disease, post-traumatic stress disorder, etc.) that may interfere with study procedures. Stable abnormal laboratory values of no more than Grade 1 determined to not be of clinical significance to the primary treating physician for that condition may be permitted per LSI discretion and comply with specific renal and liver testing requirements described in section 5.1m. vi. Pregnant or breast-feeding. vii. Insulin-dependent diabetes or diabetes not controlled on oral diabetes medications. viii. Scheduled (every 3 months or more frequently) IV or oral steroids in the year prior to enrolment. ix. IV or oral steroids in the 60 days prior to enrolment. x. Use of LA in the prior 2 years exceeding the equivalent of 1200mg daily for 3 months. xi. Participation in the pilot LA in SPMS tr...

Inclusion/Exclusion Criteria. The Registry Protocol has specifically defined inclusion and exclusion criteria for patients who may be enrolled in the follow-up. The Investigator shall fully comply with the requirements indicated in the Study Protocol.

Inclusion/Exclusion Criteria. For this analysis, we used data from ever-married women, village, and health sub-center surveys. For our two outcomes, (IFA receipt and IFA consumption), we constructed two final samples. We included women in our data analysis that had a live birth in the time period surveyed (from January 1, 2004 to 2007-08), lived in a primary sampling unit (PSU) covered by only one HSC, and had complete data for the outcome of interest and covariates. Due to these inclusion criteria, all women who did not attend ANC (and thus were not asked about IFA receipt or consumption) and those who lived in urban residences (and were not covered by an HSC) were excluded. Women with incomplete or implausible data were also excluded. In our IFA consumption model, women who did not receive IFA were not asked about consumption and therefore excluded from that model (See Figure 4.1a). We also excluded HSCs that did not cover a primary sampling unit (PSU) with an ever- married woman in our model, that covered more than one PSU, or that had missing data. In rural populations, PSUs were defined as census villages or communities24. For the IFA receipt outcome, we included 1,012 HSCs and for the IFA consumption second outcome, 890 HSCs (See Figure 4.1b). There were some differences between the total sample and our analysis samples. Women included in our models were older, more educated, of higher birth order, and less likely to be married before the age of 18 or be of a scheduled caste or tribe. Women included in our second model (IFA consumption), were more likely to have initiated ANC earlier, have more frequent ANC visits, and experienced more ANC practice and counseling. HSCs that were excluded were more likely to be in need of repair. We constructed two primary outcomes for this analysis. Both outcomes were dichotomous variables regarding IFA supplements provided during ANC as routine standard of care through the government health system. Government guidelines require one dose of IFA to be 100mg elemental iron (ferrous sulphate18) and 500 mcg folic acid from tablets or syrup26. The first outcome was defined as receipt of any iron and folic acid supplements during the last pregnancy. Interviewers asked women who reported having attended ANC how many IFA tablets or bottles they received during their last pregnancy. This included any quantity of IFA tables or IFA syrup. Those who answered any number greater than zero were classified as having received IFA 25. Women who received IFA were a...

Inclusion/Exclusion Criteria. All individuals in each household were surveyed regardless of MDA eligibility. For this study however, only individuals eligible for MDA were included. Individuals who were reportedly ineligible (too young, pregnant/lactating, or severely ill) at the time of MDA were excluded from the analysis. Observations for children under five years of age were also excluded for ALB, IVM and PZQ drug types, and children less than six months of age were excluded for ZITH. While children over two years were eligible for ALB, children under five years were ineligible for IVM, and the two drugs were administered in combination during the LF MDAs (children under five were likely skipped over for both drug types). Additional exclusions included those missing a coverage response, and observations collected using EPI and LQAS survey methods in Uganda. Data collected using the EPI and LQAS survey methods in Uganda were excluded to control for possible duplications due to surveys being conducted in the same district. Figure 1 displays the inclusion criteria and final sample sizes by country and drug type for this study. In Burkina Faso, 3,712 individuals were surveyed, 624 were excluded from this study for not meeting inclusion criteria. The final study sample size for Burkina Faso was 3,088 individuals. In Malawi, 3,595 individuals were surveyed, 549 individuals were excluded from the study, and so the final study sample size was 2,904 individuals. In Uganda, 3,949 individuals were surveyed, 1,854 were excluded due to being sampled by the EPI sampling method, and 287 were excluded due to being sampled by the LQAS sampling method. Individuals surveyed using PPS (n=1,353) were included. In Uganda, target populations varied by drug type and targeted disease. After exclusions, the sample size for ALB and IVM targeting LF was 998 and 1,001 respectively. Target population for ALB targeting soil-transmitted helminths (STH) and PZQ targeting schistosomiasis included school aged children five to fourteen years of age. After age restrictions and exclusions, the target population for treating STH with ALB included 454 school-aged children and the target population for treating schistosomiasis with PZQ included 451 children. The target population for Zithromax targeting trachoma was larger than the previous target populations due to children over six months being eligible. After exclusions, 1,146 individuals were included in the final sample size for Zithromax targeting trachoma. Figure 1:...

Inclusion/Exclusion Criteria. All patients admitted to the AVAMC acute care medical facility from October 1st, 2007, through February 1st 2008 (4 months), were eligible to be included in the study population. All patients with positive admission nasal MRSA surveillance results were included in the study. A random sample of patients from the same time period with negative admission nasal MRSA surveillance results was also included. Patients without admission nasal colonization results were excluded. Patients sent to the AVAMC for a surgical procedure with no prior or subsequent follow-up within the AVAMC system were also excluded. The inpatient psychiatric department does not perform MRSA nasal surveillance routinely and thus were excluded from the study population.

Inclusion/Exclusion Criteria. Given the overall paucity of research on HD, we aimed to include as many studies as possible. As such, any twin study reporting on heritability estimates on the hoarding phenotype regardless of study design (e.g. volunteer, population-based or register-based) was considered eligible for inclusion in the current review. Records were excluded if they were not a twin study (e.g. family, molecular genetic, animal studies) or did not report heritability estimates for the phenotype of interest. Twin studies on the same samples were included as long as the instrument utilised differed between studies (e.g. ▇▇▇▇▇▇▇▇▇ et al., 2009 and ▇▇▇▇▇▇▇▇▇ et al., 2011); on the other hand, when several publications reported on the same twin sample and measures, we opted to include the largest one reporting on univariate twin analyses on hoarding symptoms.